FDA 3627 CT X-Ray (esubmitter)

Reporting and Recordkeeping for Electronic Products - General Requirements

3627 esubmitter DX CT Blank form

Reporting for Electronic Products: General Requirements

OMB: 0910-0025

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0025 can be found here:

Document [pdf]

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Section: eRadHealth Menu
Introduction

Electronic Product Radiation Safety Reporting
Form
This software application is intended to automate the hard copy product reporting forms in the effort of the Center for Devices and
Radiological Health (CDRH) to become capable of accepting electronic submissions from industry and to improve our review
process. This FDA Electronic Submission (eSub) software is the next version of the application developed to allow us to accept all
Radiological Health reports and other submissions electronically and improve the ability of CDRH to accomplish its mandated
product and industry evaluations in a timely and efficient manner.
All electronic reports and correspondence can either be transferred to CD and mailed to the address below, or can be sent via the
FDA Electronic Submissions Gateway to CDRH. If you follow instructions to set up an account with the FDA Gateway, it currently
may take several weeks,, but when you submit through it you will receive your acknowledgement email message with Accession
Number within minutes! Or, in the interest of faster turn-around for a one-time urgent report of if you submit few reports, you may
simply fill out this template creating the submission and then at 'Packaging' follow the instructions to transfer the files to a CD to
mail in. This method of submitting your report will be acknowledged by an email with the Accession Number within several days.
Information about the FDA Electronic Submissions Gateway can be found at
www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Please contact the Gateway Helpdesk with your
questions about that system.
Electronic submissions on CD should be mailed directly to the Document Control Center at:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Submissions received in the mail on CD will be processed within a few days of receipt.
Note about eSubmitter software:
Instructions provided in this software briefly summarize the requirements of the regulations under the Federal Food, Drug and
Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of
electronic products that emit radiation. The software provides questions relevant to requirements in the performance standards and
may include explanations or clarification about the performance, labeling, and informational requirements of the standard. It does
not replace the regulations, however, and if there is any conflict between the software and the regulations, the regulations must
prevail. Throughout this application, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in
parentheses. Please consult them before making design or procedural decisions.
Regulatory requirements for radiological products can be found at http://www.fda.gov/Radiation-EmittingProducts/default.htm
and for medical devices are located at www.fda.gov/M/devaDvices/default.htm. If you have specific questions about the
regulations, please contact us at: [email protected].
If you have specific questions regarding this software, please contact the eSub team by email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your comments and suggestions to the eSub
team as often as you like.
Thank you for your continued support of the FDA Electronic Submission Program (eSub).

Definitions
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Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing, assembling,
or importing of electronic products (21 CFR1000.3(n)). Manufacturers of electronic products subject
to 21CFR1000-1050 must:

• Design and manufacture their products to be in
compliance with applicable performance standards;
• Test their products to assure compliance;
• Certify compliance of their products;
• Maintain test and distribution records and a file of
correspondence concerning radiation safety, safety
complaints, and inquiries;
• Use the published reporting forms or electronic
software application to submit reports to CDRH,
including Product reports describing the manner of
compliance of the product design and testing
program and Annual Reports summarizing their
compliance testing;
• Report accidental radiation occurrences (i.e.,
possible, suspected,or known exposures);
• Report any radiation defects or noncompliances;
and
• Recall (i.e., repair, replace, or refund the purchase
price of) defective or noncompliant products.
Importers

Importer is any person of organization engaged in the business of importing electronic products. An
importer is considered to be a manufacturer. The requirements for Manufacturers given above also
apply to importers if the requirements have not been done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
Every manufacturer of electronic products, prior to offering such product for importation into the
United States, shall designate a permanent resident of the United States as the manufacturer`s
agent upon whom service of all processes, notices, orders, decisions, and requirements may be
made for and on behalf of the manufacturer as provided in section 536(d) of the Radiation Control
for Health and Safety Act of 1968 (21U.S.C. 360mm(d)) and this section. The agent maybe an
individual, a firm, or a domestic corporation. For purposes of this section, any number of
manufacturers may designate the same agent.

From The Federal Food, Drug, and Cosmetic ActSec 536 [21 U.S.C. 360mm](d)
Designation of agent for purposes of service
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It shall be the duty of every manufacturer offering an electronic product for importation into the
United States to designate in writing an agent upon whom service of all administrative and judicial
processes, notices, orders, decisions, and requirements may be made for and on behalf of said
manufacturer, and to file such designation with the Secretary, which designation may from time to
time be changed by like writing, similarly filed. Service of all administrative and judicial processes,
notices, orders, decisions, and requirements may be made upon said manufacturer by service upon
such designated agent at his office or usual place of residence with like effect as if made personally
upon said manufacturer, and in default of such designation of such agent, service of process,
notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial
proceeding for enforcement of this part or any standards prescribed pursuant to this part may be
made by posting such process, notice, order, requirement, or decision in the Office of the Secretary
or in a place designated by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an
electronic circuit in such product.
Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or acts as part of an electronic circuit and (ii)
emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in
clause (A) and which when in operation emits (or in the absence of effect

Role
What is your role?

[L]

Note:

If you are acting as an agent of the actual manufacturer, please select your role as, for example,
perhaps an Importer or Consultant. Later in the report, under Manufacturer Data, you will be
prompted to enter both manufacturer and submitter information.

Information:

The following screen provides several options for you to accurately define what type of eSubmission
you intend to create for FDA. Below are explanations of your options. Please feel free to review this
screen, advance to the next screen and view the picklists, but if you're confused, come back to read
this screen again to be certain you are selecting the correct report or correspondence type you want
to create.

Submission Information
Use the radio buttons to identify the type of submission you are preparing. (Supplements should be prepared using the
same document type as the original submission.) [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Submission is this?
(Supplements should be submitted
selecting the same document type
as the original report.)

(
(
(
(
(

)
)
)
)
)

Radiation Safety Report (Product) Report (21 CFR 1002.10)
Annual Report (21 CFR 1002.13)
Laser Light Show Documents (all relevant documents) (21 CFR 1040.11(c))
Correspondence
Variance Request (General, not Laser Light Show) (21 CFR 1010.4)

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( ) Laser Original Equipment/Component Manufacturer Registration (21 CFR
1040.10(a)(3)(ii))
( ) Abbreviated Report (21 CFR 1002.12)
After answering the Submission Type question above, one of the questions below may become active and required (see
the blue dot to the right of the question). If there is an active question, select the appropriate product area or document
type from the question's pick list. [QUESTION TYPE NOT YET IMPLEMENTED: HEADER STEP]
What Type of Product is this Radiation Safety Report about?
[L]
What Type of Product is this Annual Report about?
[L]
What Laser Light Show Document are you filing?
[L]
What Type of Correspondence is this?
[L]
What Type of Product is this Variance Request about?
[L]

FDA or State Inspector
Abbreviated Report Applicability
OEM Laser Applicability

Section: Manufacturer Data
General Information

General Information for Radiological Health
Products
Manufacturers of products subject to performance standards under the Federal Food, Drug, and Cosmetic Act (FFDCA), Chapter V,
Subchapter C - Electronic Product Radiation Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product and Annual reports. This application will
assist manufacturers of electronic products that emit radiation in providing adequate reporting of radiation safety testing and
compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify
Reporting and Notification requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate form (21 CFR 1002.7). This software
application serves the same report responsibility, so long as the submitter or manufacturer prints out the cover letter and sends it in
along with the CD containing the report files. The submitter of the report will receive an acknowledgment letter (or email message)
with the accession number that CDRH assigns to the report. Please reference this accession number in the future when providing
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additional information about this model family in either a supplement or the annual report. If a report is incomplete or inadequate
CDRH may reject it and return it for completion. CDRH will not enter a rejected report into our database.

CDRH DOES NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is
the manufacturer's responsibility to certify that their products comply with all applicable standards
(21 CFR 1010 - 1050), based on a testing program in accordance with good manufacturing
practices. Prior to the shipment of products in interstate commerce, 21 CFR 1002 requires the
manufacturer to submit the product and Annual Reports and to comply with all applicable
importation requirements (21CFR 1005). If there are deficiencies, CDRH may disapprove the firm's
quality control and testing program, determine that the product contains a radiation defect, or
determine that the product fails to comply with a standard. CDRH will notify the manufacturer if we
make such a determination. CDRH may require the manufacturer to cease introduction into U.S.
commerce until deficiencies are corrected, and to initiate a corrective action program (21CFR 1003 1004) for products already introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all attachments are PDF files only, and the cover
letter is printed out and included with a real signature. Translate any text that appears in a language other than English into English
in a complete and accurate manner. Keep a copy (save a copy to your hard drive) of the completed report in your records.
Regulatory information is available on the Internet under www.fda.gov/Radiation-EmittingProducts/default.htm. No copyright
exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms, website, or future electronic submissions,
you may direct the comments to [email protected].
A complete Product Report is required for each product model or model family. Product Reports are now more generally referred to
as Radiation Safety Reports to distinguish the Radiological Health submissions from medical device submissions. CDRH suggests
that a complete report on one model of a family be submitted, with a separate Supplemental Report for each of the other models in
the family. The Supplemental Report should respond in detail to the parts of the form where there are differences to report,
referencing the number of the affected item. Items that are unchanged will still appear in the supplement from the original report.
When new models of a product are introduced, if the models satisfy the criteria for an established reporting exemption or if the new
models do not involve changes in radiation emission or performance requirements, then the manufacturer need not report the models
prior to introduction into commerce. Rather, the manufacturer is only required to identify them in the annual report, or in quarterly
updates to the annual report. Quarterly updates to annual reports may be submitted using the Annual Report software included in
this application. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and consistently used. Please use the terms as defined
in Section 1040.10(b) and in the IEEE Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).

Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing, and reviewing the
collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number."

Manufacturer and Report Information
Confirmation:

This Manufacturer section of this report requests names, addresses, phone numbers, etc. for your
firm, various officials of your firm, consultants who may assist in preparing the report, parent firm (if
any), importer and designated agent (for foreign firms). Some of this information is mandatory and its
absence will prevent you from completing the report submission. Because some of these entries may
be redundant, utilize the 'Contact Address Book' feature so you can save your data and reselect the
entries later and in the future. (See the upload/download buttons in upper right corner of the
screens).
You can check for missing data at any time using the "Missing Data Report" from the "Output" menu
across the top of this application. The Missing Data Report lists all missing responses that are
required (that have the blue dot).

Information:

Attention: Variance Applicants
If you are acting as an agent or consultant for, or on behalf of, or filing for, a company that will be
manufacturing or producing a Class IIIb or IV projector or laser light show or both which require an
approved variance, the following explanations may provide further clarification.
Manufacturer: This is the firm or company who is requesting the variance, will certify the product or
show, and will be the holder and owner of the variance. This is not the agent or consultant who may
be filing this report or Variance request for the manufacturer; that agent may be the submitter,
identified in a later screen.
Responsible Individual: This person works for the Manufacturer and is responsible for compliance of
the projector and/or show. In the case of laser light shows, he or she may be the company president,
CEO, or the laser light show head operator or a manager who oversees the shows.
Reporting Official: This person works for the Manufacturer and is responsible for reports,
recordkeeping, and submitting FDA required documents and correspondence.

Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the performance
standard. This firm develops and maintains the quality control and testing program that is the basis
for the certification of this product. Additionally, this firm usually is the owner of the product design
and manufacturing process design.
Be sure to enter address information for each tab below:

Select the Manufacturer's address from the Establishment Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: ESTABLISHMENT COMPLEX]

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with this
establishment.

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Select the Responsible Individual from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
CONTACT COMPLEX]

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing
all aspects of the testing and quality control procedures for certification as reported to FDA in the
product report. Documentation of changes intesting and quality control procedures submitted to FDA
must be signed by this individual.

Select the Reporting Official from Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Report Submitter
Note:

The submitter may be a consulting individual or firm providing assistance in report preparation and
maintenance. Documents or submissions such as this one that are prepared by the submitter must
have an accompanying authorization letter from the manufacturer's reporting official for authenticity.

Select the Submitter from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

[L]

Select the Parent Establishment and Contact from the Contact Address book: [QUESTION TYPE NOT YET
IMPLEMENTED: CONTACT COMPLEX]

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

[L]

Written Agreement
Item: 1 (could contain up to 10 items with none required)
Note:

The manufacturer who is certifying the product being reported is the manufacturer of record. If this
firm is not in the United States, please identify your current Importer(s).

Note:

If any of the required responses below do not apply to your designated agent, enter 'NOT
APPLICABLE' or 'NA.'

Select the Designated Agent from the Contact Address book:
Contact Name
Occupation Title
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Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
Attach a copy of written agreement with the designated U.S. agent:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Importer
Item: 1 (could contain up to 10 items with none required)
Select the Importer from the Contact Address book: [QUESTION TYPE NOT YET IMPLEMENTED: CONTACT
COMPLEX]

Additional Manufacturing Locations
Item: 1 (could contain up to 100 items with none required)
Note:

If any of the products certified in this report are manufactured at locations other than listed in the
Manufacturer Responsiblefor Product Compliance section, then the names, addresses, and FDA
registration numbers should be provided. In addition any codes used on labels to identify a
manufacturing location must be provided. Each factory location must assure all production
procedures are followed identically step by step as provided in this report.If the procedures are not the
same then separate reports should be filed.

Select the Manufacturer Address from the Establishment Address book: [QUESTION TYPE NOT YET IMPLEMENTED:
ESTABLISHMENT COMPLEX]
Code used on identification labels:

Section: Product Data
Product and Model Identification

Attention - Information about this section
In this section you'll be asked to identify several required or optional things which will help
FDA/CDRH staff to prioritize their reviews. You'll be asked to consider the following aspects:
(1) Identify your product's radiation type and the CDRH Product Code.
(2) Enter an Accession number if this will be a report supplment. If you are preparing a supplement, you'll see that after entering a
valid 7-digit Accession number many questions will no longer be required (they will either be disabled or will be optional, meaning
they will no longer have the blue dot).
(3) You will also have several questions that are of high significance for FDA/CDRH - why you might be submitting this report or
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correspondence. Please read these questions carefully, referring to the 21 CFR regulations on the website www.FDA.gov if you are
unsure if the question is relevant to your firm's situation.
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't seem to fit under other questions,
we have a final "Additional Information" question in this section which invites you to add comments and/or attach a file that
provides further information from your firm about this submission. This is the place to add that extra information.

Product Type Reported
Note:

Each product that CDRH regulates is assigned a product code by CDRH.

What is the product code?
To select the three letter product code,
- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes from which to
choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code. [QUESTION TYPE NOT YET
IMPLEMENTED: RH SINGLE PRODUCT CODE]
If Other, provide a category name for this specific product.

Examples of X-Ray Products
Product Type:

Product Examples:

Cabinet X-Ray Systems, Medical:

Counter Top Medical X-Ray Systems, In-Vitro XRay Systems

Cabinet X-Ray Systems, Non-Medical:

Industrial X-ray Systems, Explosive Detection
Systems, Security X-Ray (includes Baggage XRay), Cargo X-Ray Systems

Personnel Security Systems:

Backscatter X-Ray System, Transmission X-Ray
Security Systems

Cargo Non-Intrusive Security Systems:

Mobile Cargo Non-Intrusive Security Systems,
Stationary Cargo Non-Intrusive Security Systems

Industrial X-Ray Systems (Excluding Cabinet):

Industrial X-Ray Bottle Fill Checker, Industrial XRay Thickness Gauge, Security X-Ray Systems

Analytical X-Ray Systems, Non-Medical:

Diffraction, Spectroscopy, Fluorescence Systems

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Medical Diagnostic X-Ray Equipment:

Collimator, Radiographic System, Computed
Tomography System, Tomographic System,
Cradle, Film Changer, Image Intensified
Fluoroscopic System, Radiographic
Mobile/Portable System, Mammographic
System, X-Ray Camera, Spot Film Device, XRay Beam Limiting Device, X-Ray Controls Fluoroscopic, Radiographic, and Combination,
High-Voltage Generator, Radiographic Screen,
X-Ray Table, C-Arm Fluoroscopic X-Ray
System, X-Ray Image Receptor

Dental Diagnostic X-Ray Equipment:

Radiographic Cone, Extraoral X-Ray Unit,
Panoramic Intraoral Dental System, Intraoral XRay Source, Dental X-Ray Film Holder, Dental
X-Ray Beam Aligner, Cephalometric Devices

Therapeutic X-Ray Systems:

Therapeutic X-Ray Generator, Collimator, Tube
Housing Assembly

Veterinary X-Ray Systems:

Veterinary X-Ray Imaging Systems, Veterinary
Diagnostic X-Ray Therapy

X-Ray Bone Densitometers:

X-Ray Bone Densitometers

X-Ray Film and Film Processing Materials:

Radiographic Film, Digital Image Storage
Device, Radiographic Film/Cassette
Programmer, Radiographic-Film Automatic
Processor, Radiographic Film Dryer,
Radiographic X-Ray Film Marking System

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the Product Type [L]
Reported section?
Since this is not the first time you've reported on this type of product, then is this a report supplement to a
previously reported model family?

[L]

Provide the Accession Number of the original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here, such as
PMAs, 510(k)s, IDEs, etc. See Accession number description below.)

Are you requesting a new variance, a renewal, extension or amendment to a previous variance?
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[L]
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If you are requesting a renewal, extension, or amendment, please provide the variance number that was
issued by CDRH.
Stop:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance
Request separate from this report. To do this, open a new report (File > New) and select either
"Laser Light Show Variance Request" or "Variance Request (General, not Laser Light Show)" as your
Type of Submission in the Submission Information Screen. If you select "Variance Request (General,
not Laser Light Show)r" you must select the product for which you are requesting a variance with the
pick list in the bottom section of the screen.

Special Considerations
Note:

Check all items in this section that may apply to this submission.

Information:

If this product will require a formally approved Variance from a certain performance requirement, you
will need to complete two Reports for FDA, both (1) this Radiation Safety Report (RSR) on this
product, and (2) a Variance Request report. This eSubmitter software application package includes a
general Variance Request form as well as the specific Laser Light Show Variance Request form.
Both the Product RSR file and the appropriate Variance Request Correspondence file must be
submitted to CDRH following the regular files packaging procedures in this application. Both may be
transferred to the same CD or submitted via the FDA ESG to submit to the FDA/CDRH.
In addition, any Variance Request form must be printed out and the signed hard-copy sent to FDA's
Division of Dockets Management at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
NOTE: There is no need to send a copy of the CD to Division of Dockets Management.

Noncompliances or Defects
Does this document or any of its attachments contain:
A notification of noncompliance or defect?

[L]

You may provide an explanation and/or attach a document here:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Responses to Noncompliances or Defects
Does this document or any of its attachments contain any of these responses concerning noncompliances or defects?
A refutation of noncompliances or defects identified to your firm?

[L]

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

[L]

Corrective action plans you intend to implement to correct noncompliances or defects discovered in past or
current production?

[L]

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Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information on
design changes for future production, the design change information must be submitted in a Radiation
Safety (Product) Report or supplemental report. Both the proposed CAP and the design changes
may be submitted in one document if you prepare a product report and choose to include the CAP in
it as a file attachment. Alternatively, you may create a separate eSubmission for the CAP using the
"Correspondence" type template and selecting "Follow-up correspondence to FDA."

A description of any design changes that correct noncompliances for future production?
Note:

[L]

If you are submitting information on product design changes for future production due to a discovery
of noncompliances or defects in current production, you must use the Radiation Safety (Product)
Report template to create the report . Correspondence templates may be used to submit other
information such as a proposed corrective action plan pertaining to a noncompliance or defect.

You may add an explanation and/or attach a document here:
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (21 CFR 1010.5)?

[L]

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

[L]

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

[L]

Request for approval of alternate labeling?

[L]

Application for alternate test procedures (21 CFR 1010.13)?

[L]

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Variance Requests
Information:

Please note: in addition to responding to these questions below, a separate General Variance
Request or Laser Light Show Variance Request form must be completed and submitted to CDRH,
with a hard copy sent to FDA's Division of Dockets Management as instructed below for any variance
request. The information requested on this screen does not constitute the full structured content of
the variance request. The 2 types of Variance forms can be created in eSubmitter by selecting the
appropriate Variance submission type under the eRad Health Menu section of this application.

Message:

Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
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For all Variance requests, two submissions must be made to the FDA.
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located under Output in the Menu bar, and explained in subsection 4.3 of the User Manual. If sending
a CD & submittal letter, please mail to:
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Attn: eSubmitter Team
Document Mail Center - WO66-0609
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Additionally, a paper version (hard-copy) of the signed Variance request document should be
submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

Responses to Communications from FDA
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Private Labeling
Is the product sold by other companies under different brand names?

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Private Labeling-Table
Item: 1 (could contain up to 20 items with 1 required)
Give the name and address of the manufacturer:
Establishment Name
Division Name
Email Address
Address
Telephone Number
Fax Number
Give the firm establishment registration number of the manufacturer listed above (if
known):
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Explain how the brand names and model designations correspond with your own brand names and model designations:
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Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these
numbers has been assigned by FDA yet.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please provide an
explanation. The device regulations can be found in 21 CFR 807 - device manufacturer registration and device listing.
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Note:

See also http://www.fda.gov/MedicalDevices/default.htm for more information on medical device
premarket clearance procedures.

Section: Part 100 - Identification
101.0 Definitions

As used in this guide and 21 CFR 1020.30, 1020.31, 1020.32 and
following definitions apply:
(1) "Accessible surface" means the external surface of the enclosure or

1020.33, the

housing provided by the manufacturer.

(2) "accessory component" means
a) A component used with diagnostic x-ray systems, such as a cradle or
film changer, that is not necessary for the
compliance of the system
with applicable provisions of this subchapter but which requires an
initial determination of
compatibility with the system; or
b) A component necessary for compliance of the system with applicable
provisions of this subchapter but which may be
interchanged with similar
compatible components without affecting the system's compliance, such as
one of a set of
interchangeable beam-limiting devices; or
c) A component compatible with all x-ray systems with which it may be
installation
instructions, such as a tabletop cassette holder.

used and that does not require compatibility or

(3) "Air kerma" means kerma in air (see kerma).
(4) "Air kerma rate" (AKR) means the air kerma per unit time.
(5) "Aluminum equivalent" means the thickness of aluminum (type
specified conditions,
as the material in question.
(6) "Articulated joint" means a joint between two separate sections of a
the sections to
pivot on the line segment along which the sections join.

1100 alloy) affording the same attenuation, under

table top which joint provides the capacity for one of

(7) "Assembler" means any person engaged in the business of assembling,
replacing, or installing one or more components
into an x-ray system or
subsystem. The term includes the owner of an x-ray system or his or her
employee or agent who
assembles components into an x-ray system that is
subsequently used to provide professional or commercial services.
(8) "Attenuation block" means a block or stack of type 1100 aluminum alloy or aluminum alloy having equivalent attenuation
with dimensions 20 centimeters or larger by 20 centimeters or larger by 3.8 centimeters. When used, the attenuation block shall be
large enough to intercept the
entire x-ray beam.

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(9) "Automatic exposure control" (AEC) means a device which
automatically controls one or more technique factors in order
to obtain
at a pre-selected location(s) a required quantity of radiation.
(10) "Automatic exposure rate control" (AERC) means a device which
automatically controls one or more technique factors
in order to obtain
at a preselected location(s) a required quantity of radiation per unit
time.
(11) "Beam axis" means a line from the source through the centers of the

x-ray fields.

(12) "Beam-limiting device" means a device which provides a means to

restrict the dimensions of the x-ray field.

(13) "C-arm fluoroscope" means a fluoroscopic x-ray system in which the
image receptor and the x-ray tube housing
assembly are connected or
coordinated to maintain a spatial relationship. Such a system allows a
change in the direction of
the beam axis with respect to the patient
without moving the patient.
(14) "Cantilevered tabletop" means a tabletop designed such that the
centimeters beyond the
support.

unsupported portion can be extended at least 100

(15) "Cassette holder" means a device, other than a spot-film device,
cassette during
an x-ray exposure.

that supports and/or fixes the position of an x-ray film

(16) "Cephalometric device" means a device intended for the radiographic
of the human head.
(17) "Coefficient of variation" means the ratio of the standard

visualization and measurement of the dimensions

deviation to the mean value of a population of observations.

(18) "Computed Tomography" (CT) means the production of a tomogram byte
transmission -.
(19) "Control panel" means that part of the x-ray control upon which
hardware necessary
for manually setting the technique factors.

acquisition and computer processing of x-ray

remounted the switches, knobs, pushbuttons, and other

(20) "Cooling curve" means the graphical relationship between heat units

stored and cooling time.

(21) "Cradle" means:
(a) A removable device which supports and may restrain a patient above

an x-ray table; or

(b) A device; (i) Whose patient support structure is interposed between
the patient and the image receptor during normal use;
(ii) Which is
equipped with means for patient restraint; and (iii) Which is capable of
rotation about its long (longitudinal)
axis
(22) "CT Gantry" means tube housing assemblies, beam-limiting devices,
and covers which hold
and/or enclose these components.
(23) "Cumulative air kerma" means the total air kerma accrued from the
includes all contributions
from fluoroscopic and radiographic irradiation.

detectors, and the supporting structures, frames,

beginning of an examination or procedure and

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(24) "Diagnostic source assembly" means the tube housing assembly with
(25) "Diagnostic x-ray system" means an x-ray system designedfor
of diagnosis
or visualization.

abeam-limiting device attached.

irradiationof any part of the human body for the purpose

(26) "Dose" means the absorbed dose as defined by the International
Commission on Radiation Units and Measurements.
The absorbed dose, D, is
the quotient of de by dm, where de is the mean energy imparted by
ionizing radiation to matter of
mass dm.
(27) "Equipment" means x-ray equipment."Exposure" (X) means the quotient
of dQ by dm where dQ is the absolute value of
the total charge of the
ions of one sign produced in air when all the electrons (negatrons and
positrons) liberated by photons
in a volume element of air having mass
dm are completely stopped in air. "Exposure" is also used with a second
meaning to
refer to the process or condition during which the x-ray tube
produces x-ray radiation. Field emission equipment means
equipment which
uses an x-ray tube in which electron emission from the cathode is due
solely to action of an electric field.
(28) "Field emission equipment" means equipment which uses an x-ray tube
due solely to the action
of an electric field.

in which electron emission from the cathode is

(29) "Fluoroscopic radiation-emissions-display device" means a device,
subsystem or component that provides the displays
of AKR and cumulative
air kerma required by 1020.32(k). It includes radiation detectors, if
any, electronic and computer
components, associated software, and data
displays.
(30) "Fluoroscopic imaging assembly" means a subsystem in which x-ray
photons produce a set of fluoroscopic images or
radiographic images
recorded from the fluoroscopic image receptor. It includes the image
receptor(s), electrical interlocks, if
any, and structural material
providing linkage between the image receptor and diagnostic source
assembly.
(31) "Fluoroscopy" means a technique for generating x-ray images and
the purpose of
providing the user a visual display of dynamic processes.
(32) "General purpose radiographic x-ray system" means any
radiographic
examination of specific anatomical regions.

presenting them continuously as visible images for

radiographic-ray system which, by design, is not limited to

(33) "Half-value layer, (HVL)" means the thickness of specified material
which attenuates the beam of radiation to an extent
such that the air
kerma rate is reduced to one-half of its original value. In this
definition the contribution of all scattered
radiation, other than any
which might be present initially in the beam concerned, is deemed to be
excluded.
(34) "Image Intensifier" means a device, installed in its housing, which
corresponding light
image of higher energy density.

instantaneously converts an x-ray pattern into a

(35) "Image receptor" means any device, such as a fluorescent screen,
radiographic film, x-ray image intensifier tube, solidstate detector,
or gaseous detector, which transforms incident x-ray photons either into
visible image or into another form
which can be made into a visible
image by further transformations. In those cases where means are
provided to reselect a
portion of the image receptor, the term
"imagereceptor" shall mean the preselected portion of the device.
(36) "Image receptor support device" means, for mammography x-ray
systems, that part of the system designed to support
the image receptor
during a mammographic examination and to provide a primary protective
barrier.
(37) "Isocenter" means the center of the smallest sphere through which

the beam axis passes when the equipment moves

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through a full range of

rotations about a common center.

(38) "Kerma" (K) means the quantity as defined by the International
Commission on Radiation Units and Measurements.
The kerma, K, is the
quotient of dEtr by dm where dEtr is the sum of the initial kinetic
energies offal the charged ionizing
particles liberated by uncharged
ionizing particles in a material of mass dm. When the material is air,
the quantity is "air
kerma."
(39) "Last image hold (LIH) radiograph" means an image obtained either
by retaining one or more fluoroscopic images,
which may be temporally
integrated, at the end of a fluoroscopic exposure or by initiating a
separate and distinct
radiographic exposure automatically and
immediately in conjunction with termination of the fluoroscopic exposure.
(40) "Lateral fluoroscope" means the x-ray tube and image receptor
combination in a biplane system dedicated to the lateral
projection. It
consists of the lateral x-ray tube housing assembly and the lateral
image receptor that are fixed in position
relative to the table with the
x-ray beam axis parallel to the plane of the table.
(41) "Leakage radiation" means radiation emanating from the diagnostic

source assembly except for:

(i)The useful beam and
(ii) Radiation produced when the exposure switch or timer is not

activated.

(42) "Leakage technique factors" means the technique factors associated
measuring leakage
radiation. They are defined as follows:

with the tube housing assembly which are used in

(i)For tube housing assemblies intended for capacitor energy storage
equipment, the maximum-rated peak tube potential and
the maximum-rated
number of exposures in an hour for operation at the maximum-rated peak
tube potential with the
quantity of charge per exposure being
10millicoulombs (or 10 mAs) or the minimum obtainable from the unit,
whichever is
larger.
(ii) For diagnostic source assemblies intended for field emission
equipment rated for pulsed operation, the maximum-rated
peak tube
potential and the maximum-rated number of x-ray pulses in an hour for
operation at the maximum-rated peak tube
potential; and(iii) For all
other diagnostic source assemblies, the maximum-rated peak tube
potential and the maximum-rated
continuous tube current for the
maximum-rated peak tube potential.
(43) "Light field" means that area of the intersection of the light beam
from the beam-limiting device and one of the set of
planes parallel to
and including the plane of the image receptor whose perimeter is the
locus of points at which the
illumination is one-fourth of the maximum
in the intersection.
(44) "Line-voltage regulation" means the difference between the no-load
of the load line
potential; that is, Percent line-voltage regulation = 100(Vn
Load line potential.

and the load line potentials expressed as a percent
-Vi)/Viwhere:Vn = No-load line potential andVi =

(45) "Maximum line current" means the route mean square current in the
maximum rating.

supply line of an x-ray machine operating at its

(46) "Mode of operation" means, forfluoroscopic systems,a distinct
method of fluoroscopy or radiography selected with a set
of technique
factors or other control settings uniquely associated with the mode.
Examples of distinct modes of operation
include normal
fluoroscopy(analog or digital), high-level control fluoroscopy,
cineradiography(analog), digital
cineradiography, digital subtraction
angiography, electronic radiography using the fluoroscopic image
receptor,
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3627 DX CT Blank Product rpt (OMB 0910-0025)
andphotospot recording. In a specific mode of operation,
certain system variables affecting air kerma, air kerma rate, or image
quality, such as image magnification, x-ray field size, pulse rate,
pulse duration, number of pulses per exposure series, SID, or
optical
aperture, may be adjustable or may vary; their variation per se does not
comprise a mode of operation different than
the one that has been
selected.
(47) "Movable tabletop" means a tabletop which, when assembled for use,
supporting structure within
the plane of the tabletop.
(48) "Nonimage-intensified fluoroscopy" means fluoroscopy using only a
(49) "Peak tube potential" means the maximum value of the potential

is capable of movement with respect to its

fluorescent screen.
difference across the x-ray tube during an exposure.

(50) "Primary protective barrier" means the material, excluding filters,
exposure for
protection purposes.

placed in the useful beam to reduce the radiation

(51) "Pulsed mode" means operation of the x-ray system such that the
x-ray tube current is pulsed by the x-ray control to
produce one or more
exposure intervals of duration less than one-half second.
(52) "Quick change x-ray tube" means an x-ray tube designed for use in
(i) The tube cannot be inserted in its housing in a manner that would
requirements of
paragraphs (k) and (m) of section 1020.30;
(ii) The focal spot position will not cause noncompliance with the

its associated tube housing such that:
result in noncompliance of the system with the

provisions of sections 1020.30 through 1020.33;

(iii) The shielding within the tube housing cannot be displaced; and
(iv) Any removal and subsequent replacement of a beam-limiting device
during reloading of the tube in the tube housing will
not result in
noncompliance of the x-ray system with the applicable field limitation
and alignment requirements of 1020.31
through 1020.33.
(53) "Radiation therapy simulation system " means a radiographic or
fluoroscopic x-ray system intended for localizing the
volume to be
exposed during radiation therapy and confirming the position and size of
the therapeutic irradiation field
(54) "Radiography" means a technique for generating and recording an
withanimage(s) after
termination of the exposure.
(55) "Rated line voltage" means the range of potentials, in volts, of
the x-ray machine
is designed to operate.

x-ray pattern for the purpose of providing the user

the supply line specified by the manufacturer at which

(56) "Rated output current" means the maximum allowable load current of
(57) "Rated output voltage" means the allowable peak potential, in
generator.

the x-ray high-voltage generator.

volts, at the output terminals of the x-ray high-voltage

(58) "Rating" means the operating limits specified by the manufacturer.

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3627 DX CT Blank Product rpt (OMB 0910-0025)
(59) "Recording" means producing a permanent form of an image resulting

from x-ray photons (e.g., film, videotape).

(60) "Response time" means the time required for an instrument system to
reach 90 percent of its final reading when the
radiation-sensitive
volume of the instrument system is exposed to a step change in radiation
flux from zero sufficient to
provide a steady state midscale reading.
(61) "Scan" means the complete process of collecting x-ray transmission
data for the production of a tomogram. Data may be
collected
simultaneously during a single scan for the production of one or more
tomograms.
(62) "Scan time" means the period of time between the beginning and end
single scan.

of x-ray transmission data accumulation for a

(63) "Solid state x-ray imaging device" means an assembly, typically in
a rectangular panel configuration, that intercepts xray photons and
converts the photon energy into a modulated electronic signal
representative of the x-ray intensity over the
area of the imaging
device. The electronic signal is then used to create an image for
display and/or storage.
(64) "Source" means the focal spot of the x-ray tube.
(65) "Source-image receptor distance, (SID)" means the distance from the
image receptor.

source to the center of the input surface of the

(66) "Source-skin distance (SSD)" means the distance from the source to
tangent to the
patient skin surface.

the center of the entrant x-ray field in the plane

(67) "Spot-film device" means a device intended to transport and/or
position a radiographic image receptor between the xray source and
fluoroscopic image receptor. It includes a device intended to hold a
cassette over the input end of the
fluoroscopic image receptor for the
purpose of producing a radiograph.
(68) "Stationary equipment" means equipment which is installed in
(69) "Stationary tabletop" means a tabletop which, when assembled for
supporting structure
within the plane of the tabletop.

affixed location.
use, is incapable of movement with respect to its

(70) "Technique factors" means the conditions of operation. They are
specified as follows: I. For capacitor energy storage
equipment, peak
tube potential in kV and quantity of charge in mAs;ii. For field
emission equipment rated for pulsed
operation, peak tube potential ink
V, and number of x-ray pulses; and iii. For CT equipment designed for
pulsed operation,
peak tube potential in kV, scan time in seconds, and
either tube current in mill amperes (mA), x-ray pulse width in seconds,
and the number of x-ray pulses per scan, or the product of the tube
current, x-ray pulse width, and the number of x-ray pulses in
mAsiv. For
CT equipment not designed for pulsed operation, peak tube potential ink
V, and either tube current in mA and
scan time in seconds, or the
product of tube current and exposure time in mAs and the scan time when
the scan time and
exposure time are equivalent; and v. For all other
equipment, peak tube potential in kV, and either tube current in mA and
exposure time in seconds, or the product of tube current and exposure
time in mAs.
(71) "Tomogram" means the depiction of the x-ray attenuation propertiesof a section through a body.
(72) "Tube" means an x-ray tube, unless otherwise specified.
(73) "Tube housing assembly" means the tube housing with tube installed.
It includes high-voltage and/or filament
transformers and other
appropriate elements when they are contained within the tube housing.

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3627 DX CT Blank Product rpt (OMB 0910-0025)
(74) "Tube ratingchart" means the set of curves which specify the rated
technique factors.

limits of operation of the tube in terms of the

(75) "Useful beam" means the radiation which passes through the tube
device when the
exposure switch or timer is activated.

housing port and the aperture of the beam-limiting

(76) "Variable-aperture beam-limiting device" means a beam-limiting
the x-ray field
size at a given SID.

device which has capacity for stepless adjustment of

(77) "Visible area" means that portion of the input surface of the image
producing a visible image.
(78) "X-ray control" means a device which controls input power to the
includes
equipment such as timers, photo timers, automatic brightness
technique factors of
an x-ray exposure.

receptor over which incident x-ray photons are

x-ray high-voltage generator and/or the x-ray tube. It
stabilizers, and similar devices, which control the

(79) "X-ray equipment" means an x-ray system, subsystem, or component
thereof. Types of x-ray equipment are as
follows:(i) Mobile x-ray
equipment means x-ray equipment mounted on a permanent base with wheels
and/or casters for
moving while completely assembled;(ii) Portable x-ray
equipment means x-ray equipment designed to be hand-carried;
and(iii)Stationary x-ray equipment means x-ray equipment which is
installed in affixed location.
(80) "X-ray field" means that area of the intersection of the useful
beam and any one of the set of planes parallel to and
including the
plane of the image receptor, whose perimeter is the locus of points at
which the exposure rate is one-fourth of
the maximum in the intersection.
(81) "X-ray high-voltage generator" means a device which transforms
electrical energy from the potential supplied by the xray control to
the tube operating potential. The device may also include means for
transforming alternating current to direct
current, filament
transformers for the x-ray tube(s), high-voltage switches, electrical
protective devices, and other
appropriate elements.
(82) "X-ray system" means an assemblage of components for the controlled
production of x rays. It includes minimally an xray high-voltage
generator, an x-ray control, a tube housing assembly, a beam-limiting
device, and the necessary supporting
structures. Additional components
which function with the system are considered integral parts of the
system.
(83) "X-ray subsystem" means any combination of two or more components
requirements specified in1020.30,
1020.31 and 1020.32.

of an x-ray system for which there are

(84) "X-ray table" means a patient support device with its patient
support structure (tabletop) interposed between the patient
and the
image receptor during radiography and/or fluoroscopy. This includes, but
is not limited to, any stretcher equipped
with a radiolucent panel and
any table equipped with a cassette tray (or bucky), cassette tunnel,
fluoroscopic image receptor,
or spot-film device beneath the tabletop.
(85) "X-ray tube" means any electron tube which is designed for the

conversion of electrical energy into x-ray energy.

102.0 - Product Identification
Note:

Give the designation of the system being certified in this report:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Enter the System Designation: (If you do not use a Model Family or Brand Name, leave the field blank)
Item
Item 1

Item 2

Head and/or Body Scanner?

[L]

102.1 Certifiable component
Item: 1 (could contain up to 500 items with none required)
Certifiable Component Type

[L]

Model Designation:
Manufacturer
Certifying in this report

[L]

Product report number where certified

103.0 - Labeling / Information
Note:

In sections 103.1 - 103.5, please provide the answers to each question listed. This can be done by
either attaching a PDF file and indicating the appropriate section to review within the PDF, or by
answering each of the listed questions directly in the text boxes provided within the template. Each
attached PDF file may contain multiple pages, but only one attachment per section is allowed.

103.1 - Appendix A
Note:

Please provide the answers to each question listed by attaching a PDF file and indicating the
appropriate section to review within the PDF.

Note:

Provide copies of the following labels along with a photograph or drawing of each certifiable
component and/or system showing the location of the attached label. The standard requires that
labels be permanently affixed, legible, and accessible to view. In the case of beam limiting devices
and tube housing assemblies contained within the gantry, the identification and certification labels
shall be mounted on the component even though the component is not visible.The gantry certification
shall serve as the certifying label for the entire CT system. In addition, the date of manufacture as
indicated on the gantry label shall serve as the manufacturing date for the entire CT system.Content
21 CFR Reference1. Certification Labels1010.22. Identification Labels1010.33. Warning Labels
1020.30(j)

Attach PDF file here.
File Attachment

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[HTML Text]
Certification labels are found on PDF page numbers:
Identification labels are found on PDF page numbers:
Warning labels are found on PDF page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
103.2 - Appendix B
Note:

Please provide the answers to each question listed by either attaching a PDF file and indicating the
appropriate section to review within the PDF, or by answering each of the listed questions directly in
the text boxes provided within the template. If attaching a PDF file, please indicate the page or section
within the PDF where the answer to each question can be found.

Note:

Provide a copy of the assembler information requested below.

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

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[HTML Text]
Assembly & test instructions to assure compliance (21 CFR Reference:
1020.30(g)). PDF page numbers:
Compatibility specifications (21 CFR Reference: 1020.30(g)). PDF page numbers:
Tube reloading instructions (21 CFR Reference: 1020.30(e)). PDF page numbers:
Please provide the assembly & test instructions to assure compliance (21 CFR Reference: 1020.30(g))
[HTML Text]
Please provide the compatibility specifications (21 CFR Reference: 1020.30(g))
[HTML Text]
Please provide the tube reloading instructions (21 CFR Reference: 1020.30(e))
[HTML Text]

103.3 - Appendix C
Note:

Note:

Provide a copy of the Operator's Manual and other user information listed below. All user information
listed below shall be identified and provided in a separate section of the user instruction manual or in
a separate manual devoted only to this information.

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

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X-ray safety & maintenance schedule (21 CFR Reference: 1020.33(h)(1)). PDF
page numbers:
Tube housing assembly information (21CFR Reference: 1020.33(h)(2)). PDF page
numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
X-ray controland generator information (21CFR Reference: 1020.33(h)(3)). PDF
page numbers:
Beam-limiting device information (21CFR Reference: 1020.33(h)(4)). PDF page
numbers:
Reference plane alignment directions (21CFR Reference: 1020.33(g)(2)). PDF
page numbers:
Offset plane alignment directions (21CFR Reference: 1020.33(g)(4)). PDF page
numbers:
Instructions concerning the use of the method provided for calculation of the CT
number mean and standard deviation (21CFR Reference: 1020.33(j)(2)). PDF
page numbers:
Operating instructions (21CFR Reference: 1020.33(h)). PDF page numbers:
Please provide x-ray safety & maintenance schedule (21 CFR Reference: 1020.33(h)(1)).
[HTML Text]
Please provide tube housing assembly information (21CFR Reference: 1020.33(h)(2)).
[HTML Text]
Please provide x-ray control and generator information (21CFR Reference: 1020.33(h)(3)).
[HTML Text]
Please provide beam-limiting device information (21CFR Reference: 1020.33(h)(4)).
[HTML Text]
Please provide reference plane alignment directions (21CFR Reference: 1020.33(g)(2)).
[HTML Text]
Please provide offset plane alignment directions (21CFR Reference: 1020.33(g)(4)).
[HTML Text]
Pleaseprovide instructions concerning the use of the method provided for calculation of the CT number mean and
standard deviation (21CFR Reference: 1020.33(j)(2)).
[HTML Text]
Please provide operating instructions (21CFR Reference: 1020.33(h)).
[HTML Text]

103.4 - Appendix D
Note:

Provide a copy of the Operator's Manual and other user information listed below. Provide below the
exact page number of the location of each item. All user information listed below shall be identified
and provided in a separate section of the user instruction manual or in a separate manual devoted
only to this information.

Is this data located in a PDF file?

[L]

Attach PDF file here.

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]
A statement of the CT conditions of operation used to provide the dose information requested
below and inappendix E, part 5 (21 CFR Reference: 1020.33(c)(1)). PDF page numbers:
Dose Information (21 CFR Reference: 1020.33(c)(2)) and Imaging Performance Information
(1020.33(c)(93)). PDF page numbers:
a

Note:

CTDI along the axis of rotation of the phantom and along lines parallel to the axis of rotation
and 1.0 centimeter interior to the surface of the phantom and 90 0 apart. One of the surface
positions shall be the maximum CTDI obtainable at the 1.0 centimeter depth.The CT
conditions of operation (e.g., kVp, mAs, slice thickness, scan diameter, etc.) shall be the
typical values. The location of the phantomposition where the surface (1 cm interior) CTDI is
maximum shall be indicated with respect to the CT system.

A statement of the noise. PDF page numbers:
b

Note:

CTDI in the centerlocation of the phantom for each selectable CT condition of operation that
varies either the rate or duration of the exposure. Each condition of operation shall be
presented as normalized to the value in (a) above with the other conditions of operation the
same as in (a). If more than three selections for a condition of operation are available the
normalized values shall be given for the maximum, minimum, and an intermediateselection.

A graphical presentation of the modulation transfer function for the same imaging
processing & presentation mode as that used in the statement of the noise. PDF
page numbers:
c

Note:

CTDI at the location of the maximum CTDI at 1.0 centimeter interior to the surface of the
phantom for each selectable peak tube potential. If more than three selectionsare available,
the normalized values shall be given for the maximum, minimum, and an intermediate
selection.

A statement of the nominal tomographic section thickness(es). PDF page numbers:
d

Note:

Dose profile in the center location of the dosimetry phantom for each selectable nominal
tomographic section thickness. If more than three selections of section thickness are available,
the normalized values shall be given for the maximum, minimum, and an intermediate
thickness. The dose profile shall be on the same graph and to the same scale as the
corresponding sensitivity profile.

A graphical presentation of the sensitivity profile, as measured in the center of the
dosimetry phantom for the selectable nominal tomographic section thickness for
which the dose profiles are given. This shall be presented on the same graph and to
the same scale as the corresponding dose profiles. The nominal section thickness
shall be defined as the distance between the 50% sensitivity points on the sensitivity
curve. PDF page numbers:
e

Note:

A statement of the accuracy of the values given in a through d above.

A description of the phantom or device and test protocol or procedure used to
determine the specifications and a statement of the maximum deviation from the
specifications for items (a-d) above. PDF page numbers:
A statement of the CT conditions of operation used to provide the dose information requested below and in appendix E,
part 5 (21 CFR Reference: 1020.33(c)(1))
[HTML Text]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Dose Information (21 CFR Reference: 1020.33(c)(2)) and Imaging Performance Information (1020.33(c)(93))
[HTML Text]
a

Note:

CTDI along the axis of rotation of the phantom and along lines parallel to the axis of rotation
and 1.0 centimeter interior to the surface of the phantom and 90 0 apart. One of the surface
positions shall be the maximum CTDI obtainable at the 1.0 centimeter depth. The CT
conditions of operation (e.g., kVp, mAs, slice thickness, scan diameter, etc.) shall be the
typical values. The location of the phantom position where the surface (1 cm interior) CTDI is
maximum shall be indicated with respect to the CT system.

A statement of the noise
[HTML Text]
b

Note:

CTDI in the center location of the phantom for each selectable CT condition of operation that
varies either the rate or duration of the exposure. Each condition of operation shall be
presented as normalized to the value in (a) above with the other conditions of operation the
same as in (a). If more than three selections for a condition of operation are available the
normalized values shallbe given forthe maximum, minimum, and an intermediate selection.

A graphical presentation of the modulation transfer function for the same imaging processing & presentation
mode as that used in the statement of the noise
[HTML Text]
c

Note:

CTDI at the location of the maximum CTDI at 1.0 centimeter interior to the surface of the
phantom for each selectable peak tube potential. If more than three selections are available,
the normalized values shall be given for the maximum, minimum, and an intermediate
selection.

A statement of the nominal tomographic section thickness(es)
[HTML Text]
d

Note:

A graphical presentation of the sensitivity profile,as measured in the center of the dosimetry phantom for the
selectable nominal tomographic section thickness for which the dose profiles are given. This shall be
presented on the same graph and to the same scale as the corresponding dose profiles. The nominal
section thickness shall be defined as the distance between the 50% sensitivity points on the sensitivity
curve.
[HTML Text]
e

Note:

A statement of the accuracy of the values given in a through d above.

103.5 - Appendix E
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 26 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
within the PDF where the answer to each question can be found.
Note:

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

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[HTML Text]
Quality assurance instructions*(21 CFR Reference: 1020.33(d))
1.

Phantom description. PDF page numbers:

Instructions on phantom use and schedule for use. PDF page numbers:

Listing of allowable variations for the indicated parameters. PDF page numbers:

Description of the method to store quality assurance data. PDF page numbers:

Representative images obtained or a description of the means used tostore and display
such images. PDF page numbers:

Quality assurance instructions*(21 CFR Reference: 1020.33(d))
Phantom description.
[HTML Text]
Instructions on phantom use and schedule for use.
[HTML Text]
Listing of allowable variations for the indicated parameters.
[HTML Text]
Description of the method to store quality assurance data.
[HTML Text]
Representative images obtained or a description of the means used to store and display such images.
[HTML Text]
Note:

*QA tests for noise, contrast scale, nominal tomographic section thickness, and mean CT number
should be done through the data acquisition stage. Resolution tests of either high or low contrast
objects should be done from measurements through the data acquisition and display stages. The QA
tests on resolution could be performed as two independent tests, i.e., one test operating on the digital
data and one test operating on the display device. The test for contrast scale should include materials
with CT numbers close to water so that they are representative of the CT number scale of interest to
the user. At least two materials different from water should be used, one with a CT number
approximately plus 100-300 and the other with a CT number of minus 100-300.

Section: Part 200 - System Description
201.0 - Control/Indication CT Conditions of Operation - Visual Indication
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Note:

Give a complete description of the means provided to satisfy the requirement.

All CT conditions of operation must be displayed prior to the initiation of each scan or scan sequence (1020.33(f)(1)).
Along witha description of the means provided, you should include a drawing or picture of the preindicators of technique
factors to the operator. Click on the Add... button below to attach any supporting files.
Details

[HTML Text]

File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv,
.zip)]

The displayed conditions of operation must be visible from any position from which scan initiation is possible
(1020.33(f)(1)). Provide a drawing or picture that illustrates the proximity of any exposure switch to the
preindicatedtechnique factors. Click on the Add... button below to attach any supporting files.
Details

[HTML Text]

File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv,
.zip)]

202.0 - Control/Indication of the CT Conditions of Operations - Timers
Note:

Please provide the answers to each question listed by either attaching a PDF file and indicatingthe
appropriate section to review within the PDF, or byanswering each of the listed questions directly in
the text boxes provided within the template. If attaching a PDF file, please indicate the page or section
within the PDF where the answer to each question can be found.

Note:

Give a complete description of the means provided to satisfy the requirement.

Is this data located in a PDF file?

[L]

Attach only one PDF file here.
File Attachment

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[HTML Text]
In the event of equipment failure, means must be provided to automatically limit the total scan
time to no more than 110% of its preset value (1020.33(f)(2)(i)). Give a complete description of
the backup safety device which is provided for this requirement. PDF page numbers:
Visual indication must be provided to identify scans terminated through these means
(1020.33(f)(2)(i)). In addition to a description of the means provided, you should include a picture
or drawing of the visible signal that indicates when an exposure has been terminated by the
backup safety device. PDF page numbers:
Means must be provided for the manual resetting of the conditions of operation, in the event of
equipment failure, prior to the initiation of another scan (1020.33(f)(2)(i)). Describe the manual
resetting procedures. PDF page numbers:
Means must be provided such that the exposure from the system does not exceed the radiation
levels specified in paragraph 1020 30(k) except when x ray transmission data are being collected
for use in image production or technique factor selection (1020.33(f)(2)(ii)). Give a description of
your design which will limit the dose to the patient to only those circumstances stated above.
PDF page numbers:
Means must be provided for the operator to terminate the x ray exposure at any time during a
scan, or series of scans of greater than 0.5 seconds duration (1020.33(f)(2)(iii)). Describe this
method. PDF page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Termination of the x ray exposure, by the operator, must require manual resetting of the
conditions of operation prior to initiation of another scan (1020.33(f)(2)(iii)). Describe the manual
resetting procedure. PDF page numbers:
In the event of equipment failure, means must be provided to automatically limit the totalscan time to no more than
110% of its preset value (1020.33(f)(2)(i)). Give a complete description of the backup safety device which is provided for
this requirement.
[HTML Text]
Visual indication must be provided to identify scans terminated through these means (1020.33(f)(2)(i)). In addition to a
description of the means provided, you should include a picture or drawing of the visible signal that indicates when an
exposure has been terminated by the backup safety device.
[HTML Text]
Means must be provided for the manual resetting of the conditions of operation, in the event of equipment failure, prior
to the initiation of another scan (1020.33(f)(2)(i)). Describe the manual resetting procedures.
[HTML Text]
Means must be provided such that the exposure from the system does not exceed the radiation levels specified in
paragraph 1020 30(k) except when x ray transmission data are being collected for use in image production or technique
factor selection (1020.33(f)(2)(ii)). Give a description of your design which will limit the dose to the patient toonly those
circumstances stated above.
[HTML Text]
Means must be provided for the operator to terminate the x ray exposure at any time during a scan, or series of scans of
greater than 0.5 seconds duration (1020.33(f)(2)(iii)). Describe this method.
[HTML Text]
Termination of the x ray exposure, by the operator, must require manual resetting of the conditions of operation prior to
initiation of another scan (1020.33(f)(2)(iii)). Describe the manual resetting procedure.
[HTML Text]

203.0 - Tomographic Plane Indication & Alignment
Note:

Please provide the answers to each question listed by either attaching a PDF file and indicating the
appropriate section to review within thePDF, or by answering each of the listed questions directly in
the text boxes provided within the template. If attaching a PDF file, please indicate the page or section
within the PDF where the answer to each question can be found.

Note:

Give a complete description of the means provided to satisfy the requirement.

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]
For any single tomogram, system, means shall be provided to permit visual determination of the
tomographic plane or an offset reference plane (1020.33(g)(1)). Describe thespecific means
utilized for indication of location on the patient where the tomogram will be obtained. PDF page
numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
For any multiple tomogram system, means must be provided to permit visual determination of the
location of a reference plane (1020.33(g)(2)). For multiple tomogram systems, describe the
relationship of the reference plane alignment to the actual position of the tomograms. PDF page
numbers:
For any single tomogram, system, means shall be provided to permit visual determination of the tomographic plane or
an offset reference plane (1020.33(g)(1)). Describe the specific means utilized for indication of location on the patient
where the tomogram will be obtained.
[HTML Text]
For any multiple tomogram system, means must be provided to permit visual determination of the location of a reference
plane (1020.33(g)(2)). For multiple tomogram systems, describe the relationship of the reference plane alignment to the
actual position of the tomograms.
[HTML Text]

204.0 - Beam On and Shutter Status Indicators
Note:

Note:

Give a complete description of the means provided to satisfy the requirement.

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]
Means shall be provided on the x ray control and on or near the housing of the scanning
mechanism to provide visual indication when and only when X rays are produced (1020.33(h)(1)).
In addition to a description of this means, provide a drawing or picture to show visual indicators.
PDF page numbers:
If applicable, means shall be provided on the x ray control and on or near the housing of the
scanning mechanism to provide visual indication of whether the shutter is open or closed
(1020.33(h)(1)). In addition to a description of this means, provide a drawing or picture to show
the visual indicators. PDF page numbers:
The minimum period for x ray on indication must be 0.5 seconds or greater (1020.33(h)(1)).
Describe the means provided to meet this requirement. PDF page numbers:
Visual indicators (indicating x ray production and shutter status) on or near the housing of the
scanning mechanism shall be discernible from any point external to the patient opening, where
insertion of any part of the human body into the primary beam is possible (1020.33(h)(1)). In
addition to the description of this means, provide a drawing or picture that illustrates the location
of all indicators at or near the housing of the scanning mechanism, in relation to the patient
opening. PDF page numbers:
Means shall be provided on the x ray control and on or near the housing of the scanning mechanism to provide visual
indication when and only when X rays are produced (1020.33(h)(1)). In addition to a description of this means, provide a
drawing or picture to show visual indicators.
[HTML Text]
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
If applicable, means shall be provided on the x ray control and on or near the housing of the scanning mechanism to
provide visual indication of whetherthe shutter is open or closed (1020.33(h)(1)). In addition to a description of this
means, provide adrawing or picture to show the visual indicators.
[HTML Text]
The minimum period for x ray on indication must be 0.5 seconds or greater (1020.33(h)(1)). Describe the means
provided to meet this requirement.
[HTML Text]
Visual indicators (indicating x ray production andshutter status) on or near the housing of the scanning mechanism shall
be discernible from any point external to the patient opening, where insertion of any part of the human body into the
primary beam is possible(1020.33(h)(1)). In addition to the description of this means, provide a drawing or picture that
illustrates the location of all indicators at or near the housing of the scanning mechanism, in relation to the patient
opening.
[HTML Text]

205.0 - CT Number Mean and Standard Deviation
Note:

Note:

Give a complete description of the means provided to satisfy the requirement.

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]
Means must be provided for the user to calculate the mean and standard deviation of CT
numbers for an array of picture elements about any location in the image (1020.33(j)(1)).
Describe this means. PDF page numbers:
The number of elements in this array must be under user control (1020.33(j)(1)). Describe the
means provided to the user for varying the number of elements in the array.PDF page numbers:
Means must be provided for the user to calculate the mean and standard deviation of CT numbers for an array of picture
elements about any location in the image (1020.33(j)(1)). Describe this means.
[HTML Text]
The number of elements in this array must be under user control (1020.33(j)(1)). Describe the means provided to the
user for varying the number of elements in the array.
[HTML Text]

206.0 - Labeling
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Note:

Give a complete description of the means provided to satisfy the requirement.

Is this data located in a PDF file?

[L]

Attach PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]
The warning label must be legible and clearly visible on the control panel containing the main
power switch (1020.30(j)). PDF page numbers:
The identification label must contain the name & address of the manufacturer (or the individual or
company under whose name it was sold), the place of manufacture, & the model designation and
serial number (1010.3(a)(1)(2)). PDF page numbers:
The month and year of manufacture must be provided clearly & legibly without abbreviation, and
with the year shown as a four digit number follows: manufactured: (insert month and year of
manufacture) (1010.3(a)(2)(ii)). PDF page numbers:
If the place of manufacture as stated on the identification label is coded, please provide that code
(1010.3(a)(2)(i)). PDF page numbers:
The warning label must be legible and clearly visible on the control panel containing the main power switch (1020.30(j)).
[HTML Text]
The identification label must contain the name & address of the manufacturer (or the individual or company under whose
name it was sold), the place of manufacture, & the model designation and serial number (1010.3(a)(1)(2)).
[HTML Text]
The month and year of manufacture must be provided clearly & legibly without abbreviation, and with the year shown as
a four digit number follows: manufactured: (insert month and year of manufacture) (1010.3(a)(2)(ii)).
[HTML Text]
If the place of manufacture as stated on the identification label is coded, please provide that code (1010.3(a)(2)(i)).
[HTML Text]

Section: Part 300 - Quality Control
301.0 - Leakage Radiation From the Diagnostic Source Assembly
Note:

Please provide the answers to each question listed by either attaching a PDF file and in subsequent
questions identify the appropriate section to review within the PDF, or by answering each of the listed
questions directly in the text boxes provided. If attaching a PDF file, please indicate the page or
section within the PDF where the answer to each question can be found.

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
301.1 Requirement
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

The leakage radiation from the diagnostic source assembly measured at distance of 1 meter in any direction from the
source shall not exceed 100 milliroentgens in 1hour when the x ray tube is operated at its leakage technique factors.
Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear
dimension greater than 20 centimeters (1020.30(k)). PDF page numbers:

The leakage radiation from the diagnostic source assembly measured at distance of 1 meter in any direction from the
source shall not exceed 100 milliroentgens in 1 hour when the x ray tube is operated at its leakage technique factors.
Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear
dimension greater than 20 centimeters (1020.30(k)).
[HTML Text]

301.2 Critical Parameters and "Worst Case" Conditions
Note:

a. The test results must include data representative of each compatible combination of tube housing assembly, beam
limiting device, and gantry. b. To assure the use of maximum rated peak tube potential and continuous tube current, the
test method(s) must provide the procedure for periodic calibration of technique factors.c. For any test using a scan of
the diagnostic source assembly, the rate of scan specified in the test method(s) must account for the response time of
the radiation instrumentation.d.Please note and describe any critical parameters and "worst case" conditions which are
unique to your system or test method. PDF page numbers:
[HTML Text]
a. The test results must include data representative of each compatible combination of tube housing assembly, beam
limiting device, and gantry.b. To assure the use of maximum rated peak tube potential and continuous tube current, the
test method(s) must provide the procedure for periodic calibration of technique factors.c. For any test using a scan of
the diagnostic source assembly, the rate of scan specified in the test method(s) must account for the response time of
the radiation instrumentation.d. Please note and describe any critical parameters and "worst case" conditions which are
unique to your system or test method.
[HTML Text]

301.3 Prototype Testing
Note:

Page 33 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete withan explanation of any correction factors employed.e. A statement indicating
whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thicknessat the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:
[HTML Text]
a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

301.4 Production Testing
Note:

a. Describe all methods employed in direct and indirect testing of each modelwith respect to this requirement.b. If an
indirect test is used to measure compliance, explain why it is an accurate indication of compliance with this
requirement.c. Submit the technical data that supports the use of the test in part b.d. Provide a copy of the detailed
instructions for performing each test. Attach as APPENDIX F.e. Identify the instrument(s) used for each test by
manufacturer and model number. Answer the appropriate section in Part 400 foreach instrument(s).f. For each of the
above test methods give the page number of your detailed instructions for performing the test and indicate where the
rejection limits are specified.g. For each of the above test methods, provide sample raw test data.h. If the actual
compliance value is calculated from the raw test data, provide a sample of calculated compliance values complete with
an explanation of any correction factors employed.j. A statement indicating whether the maximum CTDI is obtained
from integration of the dose profile for a single scan or from a direct measurement of the average dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:
[HTML Text]
a. Describe all methods employed in direct and indirect testing of each model with respect to this requirement.b. If an
indirect test is used to measure compliance, explain why it is an accurate indication of compliance with this
requirement.c. Submit the technical data that supports the use of the test in part b.d. Provide a copy of the detailed
instructions for performing each test. Attach as APPENDIX F.e. Identify the instrument(s) used for each test by
manufacturer and model number. Answer the appropriate section in Part 400 for each instrument(s).f. For each of the
above test methods give the page number of your detailed instructions for performing the test and indicate where the
rejection limits are specified.g. For each of the above test methods, provide sample raw test data.h. If the actual
compliance value is calculated from the raw test data, provide a sample of calculated compliance values complete with
an explanation of any correction factors employed.j. A statement indicating whether the maximum CTDI is obtained
from integration of the dose profile for a single scan or from a direct measurement of the average dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness.
[HTML Text]
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
301.4i Sampling
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

List each performance parameter test that is sampled.
[HTML Text]
Describe the sampling plan used for each performance test and provide the parameters of the plan listed below (e.g., lot
size, sample size, rejection criterion). Attach a copy of the plan.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

301.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer the questions in 301.4 with respect to assembler testing.
Note: The information requested in 301.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
a-i. If test instructions are provided to the assembler, answer the questions in 301.4 with respect to assembler testing.
Note: The information requested in 301.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

302.0 - Beam Quality
Note:

Is this data located in aPDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

302.1 Requirement
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions.As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

The half value layer of the useful beam for a given x ray tube potential shall not be less than the values shown in Table I
of the diagnostic x ray standard (see 1020.30(m)). PDF page numbers:

The half value layer of the useful beam for a given x ray tube potential shall not be less than the values shown in Table I
of the diagnostic x ray standard (see 1020.30(m)).
[HTML Text]

302.2 Critical Parameters and "Worst Case" Conditions
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions.As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a. The test results must includedata representative of each compatible combination of tube housing assembly and
beam limiting device.b. Since the peak tube potential has a critical effect on determining the half value layer, the test
method(s) must provide the procedure for periodic calibration of tube potential.c. To minimize the effect of scatter
radiation, the x ray field specified in the test method(s) must be just large enough to cover the sensitive volume of the
detector.d. Please note and describe any critical parameters and "worst case" conditions which are unique to your
system or test method. PDF page numbers:

a. The test results must include data representative of each compatible combination of tube housing assembly
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 36 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
andbeam limiting device.b. Since the peak tube potential has a critical effect on determining the half value layer, the
test method(s) must provide the procedure for periodic calibration of tube potential.c. To minimize the effect of scatter
radiation, the x ray field specified in the test method(s) mustbe just largeenough to cover the sensitive volume of the
detector.d. Please note and describe any critical parameters and "worst case" conditionswhich are unique to your
system or test method.
[HTML Text]

302.3 Prototype Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions.As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identifythe instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If theactual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

302.4 Production Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions.As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

Page 37 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)

302.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

List each performance parameter test that is sampled.
[HTML Text]
Describe the sampling plan used for each performance test andprovide the parameters of the plan listed below (e.g., lot
size, sample size, rejection criterion). Attach a copy of the plan.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Page 38 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

302.5 Assembler Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions.As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a-i.If test instructions are provided to the assembler, answer the questions in 302.4 with respect to assembler testing.
Note: The information requested in 302.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 302.4 with respect to assembler testing.
Note: The information requested in 302.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

303.0 - Peak Tube Potential
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions askedin
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

303.1 Requirement
Note:

The manufacturer shall state the maximum deviation of the peak tube potential from its preindicated value during an
exposure when the equipment is connected to an adequate power supply as specified by the manufacturer. The
deviation of the pe4 tube potential shall not exceed the limits given (see 1020.30(h)(3)(vi)). PDF page numbers:
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 39 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)

303.2 Critical Parameters and "Worst Case" Conditions
Note:

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for"worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum, and
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case"
conditions which are unique to your system or test method. PDF page numbers:

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum, and
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case"
conditions which are unique to your system or test method.
[HTML Text]

303.3 Prototype Testing
Note:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of thedose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or froma direct
measurement of theaverage dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 40 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
[HTML Text]

303.4 Production Testing
Note:

303.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

List each performance parameter test that is sampled.
[HTML Text]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 41 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Describe the sampling plan used for each performance test and provide the parameters of the plan listed below (e.g.,
lotsize, sample size, rejection criterion). Attach a copy of the plan.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The lot size (N)
The sample size (n)
The reject level number (c)
A single or double samplingplan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

303.5 Assembler Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherentinaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a-i. If test instructions are provided to the assembler, answer the questions in 303.4 with respect to assembler testing.
Note: The information requested in 303.5 (d) (i.e., a copy of detailed instructionsfor performing each test) should have
already been provided in APPENDIX B and thus may bereferenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 303.4 with respect to assembler testing.
Note: The information requested in 303.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

304.0 - Tube Current
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 42 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

304.1 Requirement
Note:

For each applicable test listed below, verify that the testing adequatelyreflects the critical parameters
andaddresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

The manufacturer shall state the maximum deviation of the tube current from its preindicated value during an exposure,
when the equipment is connected to an adequate power supply as specified by the manufacturer. The deviation of the
tube current shall not exceed the limits given (see 1020.30(h)(3)(vi)). PDF page numbers:

The manufacturer shall state the maximum deviationof the tube current from its preindicated value during an exposure,
when the equipment is connected to an adequate power supply as specified by the manufacturer. The deviation of the
tube current shall not exceed the limits given (see 1020.30(h)(3)(vi)).
[HTML Text]

304.2 Critical Parameters and "Worst Case" Condition
Note:

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum, and
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case"
conditions which are unique to your system or test method. PDF page numbers:

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum, and
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case"
conditions which are unique to your system or test method.
[HTML Text]

304.3 Prototype Testing
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 43 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Note:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or froma direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value iscalculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

304.4 Production Testing
Note:

Page 44 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
compliance value is calculated from the raw test data, provide a sample of calculated compliance values complete with
an explanation of any correction factors employed.j. A statement indicating whether the maximum CTDI is obtained
from integration of the dose profile for a single scan or from a direct measurement of the average dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness.
[HTML Text]

304.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
Theacceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 45 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
303.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer thequestions in 304.4 with respect to assembler testing.
Note: The information requested in 304.5 (d) (i.e., a copy of detailed instructions for performingeach test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 304.4 with respect to assembler testing.
Note: The information requested in 304.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

305.0 - Scan Time
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]

305.1 Requirement
Note:

The manufacturer shall state the maximum deviation of the scan time from its preindicated value during anexposure,
when the equipment is connected to an adequate power supply as specified by the manufacturer. The deviation of scan
time shall not exceed the limits given (see 1020.30(h)(3)(vi)). PDF page numbers:

The manufacturer shall state the maximum deviation of the scan time from its preindicated value during an exposure,
when the equipment is connected to an adequate power supply as specified by the manufacturer. The deviation of scan
time shall not exceed the limits given (see 1020.30(h)(3)(vi)).
[HTML Text]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 46 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
305.2 Critical Parameters and "Worst Case" Conditions
Note:

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum and
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and"worst case"
conditions which are unique to your system or test method. PDF page numbers:

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum and
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case"
conditions which are unique to your system or test method.
[HTML Text]

305.3 Prototype Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any testmust be sufficiently restrictive to account for these
inaccuracies.

a. Provide adescription of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

305.4 Production Testing
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 47 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
inaccuracies.
a. Describe all methods employed in direct and indirect testing of each model with respect to this requirement.b. If an
indirect test is used to measure compliance, explain why itis an accurate indication of compliance with this
requirement.c. Submit the technical data that supports the use of the test in part b.d. Provide a copy of the detailed
instructions for performing each test. Attach as APPENDIX F.e. Identify the instrument(s) used for each test by
manufacturer and model number. Answer the appropriate section inPart 400 foreach instrument(s).f. For each of the
above test methods give the page number of your detailed instructions for performing the test and indicate where the
rejection limits are specified.g. For each of the above test methods, provide sample raw test data.h. If the actual
compliance value is calculated from the raw test data, provide a sample of calculated compliance values complete with
an explanation of any correction factors employed.j. A statement indicating whether the maximum CTDI is obtained
from integration of the dose profile for a single scan or from a direct measurement of the average dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

305.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate thePDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

List each performance parameter test that is sampled.
[HTML Text]
Describe the sampling plan usedfor each performance test and provide the parameters of the plan listed below (e.g., lot
size, sample size, rejection criterion). Attach a copy of the plan.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The lot size (N)

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

305.5 Assembler Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuraciesof the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a-i. If test instructions are provided to the assembler, answer the questions in 305.4 with respect to assembler testing.
Note: The information requested in 305.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 305.4 with respect to assembler testing.
Note: The information requested in 305.5 (d) (i.e., a copyof detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

306.0 - Tube Current - Exposure Time Product
Note:

Is this data located in a PDF file?

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

[L]

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

306.1 Requirement
Note:

The manufacturer shall state the maximum deviation of the tube current exposure time product (mAs) from its
preindicated value during an exposure, when the equipment is connected to an adequate power supply as specified by
the manufacturer. The deviation of the tube current exposure time product shall not exceed the limits given (see
1020.30(h)(3)(vi)). PDF page numbers:

306.2 Critical Parameters and "Worst Case" Conditions
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. Asa result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a. To assure compliance with the maximum deviation statements provided to the user, the test results must include
data for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimumand
maximum allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case',
conditions which are unique to your system or test method. PDF page numbers:

a. To assure compliance with the maximum deviation statements provided to the user, the test resultsmust include data
for "worst case" combinations of technique factors and supply line conditions (e.g., highest kW, minimum and maximum
allowable line voltage regulation).b. Please note and describe any critical parameters and "worst case', conditions
which are unique to your system or test method.
[HTML Text]

306.3 Prototype Testing
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each modelwith respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturerand model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e.A statement indicating
whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a seriesof 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

306.4 Production Testing
Note:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
[HTML Text]

306.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameterstested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot untilsampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

306.5 Assembler Testing
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.
a-i. If test instructions are provided to the assembler, answer the questions in 306.4 with respect to assembler testing.
Note: The information requested in 306.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 306.4 with respect to assembler testing.
Note: The information requested in 306.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

307.0 - CTDI/Dose Profile Information
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Indicate for each modality, e.g., head, body, or spine procedure:a. A statement of the typical scan technique factors
(e.g., kVp, mAs, pulse width, time, etc.)b. A statement of the scan diameter.c. A statement of the system slice
thicknesses.d. A statement of the accuracy of the parameters indicated above.e. A statement indicating whether the
maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct measurement of the
average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are spaced by the
nominal tomographic slice thickness.f. A statement of accuracy of the exposure measurement.Pages:

307.1 Requirement
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a resultof inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
The manufacturer shall state the maximum deviation of the dose values given to the user in accordance with sections
1020.33(c)(2)(i), (ii), (iii), and (iv). The deviation from these values shall not exceed the limits given (1020.33(c)(2)(v)).
PDF page numbers:

The manufacturer shall state the maximum deviation of the dose values given to the user in accordance with sections
1020.33(c)(2)(i), (ii), (iii), and (iv). The deviation from these values shall not exceed the limits given (1020.33(c)(2)(v)).
[HTML Text]

307.2 Critical Parameters and "Worst Case" Conditions
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As aresult of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a. All dose measurements must be performed with the CT dosimetry phantom placed on the patient couch or support
device without additional attenuating materials present.b. The CT conditions of operation for obtaining the CTDI at the
five specified locations shall correspond to typical values (e.g., kVp, mAs, scan diameter slice thickness) suggested by
the manufacturer for CT of the head, body, or spine as may be appropriate.c. The normalized CTDI values must be at
leastthe minimum, maximum mid range values for the condition of operation or the values available with the other
conditions of operation set atthe typical values.d. Please note any assumptions made in or limitations of your
testmethods in determining the dose values for your system. PDF page numbers:

a. All dose measurements must be performed with the CT dosimetry phantom placed on the patient couch or support
device without additional attenuating materials present.b. The CT conditions of operation for obtaining the CTDI at the
five specified locations shall correspond to typical values (e.g., kVp, mAs, scan diameter slice thickness) suggested by
the manufacturer for CT of the head, body, or spine as may be appropriate.c. The normalized CTDI values must be at
least the minimum, maximum mid range values for the condition of operation or the values available with the other
conditions of operation set atthe typical values.d. Please note any assumptions made in or limitations of your test
methods in determining the dose values for your system.
[HTML Text]

307.3 Prototype Testing
Note:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actualcompliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the testby manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dosein an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

307.4 Production Testing
Note:

For eachapplicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

307.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 55 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the producedmodels?

[L]

Are any performance parameters tested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

307.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer the questions in 307.4 with respect to assembler testing.
Note: The information requested in 307.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
a-i. If test instructions are provided to the assembler, answer the questions in 307.4 with respect to assembler testing.
Note: The information requested in 307.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

308.0 - Imaging Performance
Note:

Please provide the answers to each question listed by either attaching a PDF file and in subsequent
questions identify the appropriate sectionto review within the PDF, or by answering each of the listed
questions directly in the text boxes provided. If attaching a PDF file, please indicate the page or
section within the PDF where the answer to each question can be found.

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

308.1 Requirement
Note:

The manufacturer shall state the maximum deviation from the specifications regarding imaging performance provided in
accordance with section 1020.33(c)(3)(i), (ii), (iii), and (iv). The deviation from these values shall not exceed the limits
given (1020.33(c)(3)(v)).Questions in this section should be answered as they relate to each of the items listed in the
specified paragraphs of 1020.33(c)(3). PDF page numbers:

The manufacturer shallstate the maximum deviation from the specifications regarding imaging performance provided in
accordance with section 1020.33(c)(3)(i), (ii), (iii), and (iv). The deviation from these values shall not exceed the limits
given (1020.33(c)(3)(v)).Questions in this section should be answered as they relate to each of the items listed inthe
specified paragraphs of 1020.33(c)(3).
[HTML Text]

308.2 Critical Parameters and "Worst Case" Conditions
Note:

a. The CT conditions of operation shall correspond to those us( 1020.33(c)(2)(i), the typical conditions of operation
suggel the manufacturer or CT of the head, body, or spine as may be appropriate.b. All aspects of data collection
including the x ray attenuat properties of the material in the tomographic section shall similar to those used to provide
the dose information required section 1020.33(c)(2)(i).c. Please note any assumptions made in, or limitations of, the
methods in determining the imagingparameters. PDF page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)

308.3 Prototype Testing
Note:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated fromthe raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an intervalequal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a.Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed in
testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide asample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in aninterval equal to the slice thickness at the center of a series of 14 scans that are
spaced bythe nominal tomographic slice thickness.
[HTML Text]

308.4 Production Testing
Note:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
from integration of the dose profile for a single scan or from a direct measurement of theaverage dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

308.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

List each performance parameter test that is sampled.
[HTML Text]
Describe the sampling plan used for each performance test and provide the parameters of the plan listed below (e.g., lot
size,sample size, rejection criterion). Attach a copy of the plan.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

Page 59 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

308.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer the questions in 308.4 with respect to assembler testing.
Note: The information requested in 308.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 308.4 with respect to assembler testing.
Note: The information requested in 308.5 (d) (i.e., a copy of detailed instructions for performing each test) should
havealready been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

309.0 - Equipment Failure Exposure Termination ....
Note:

Please provide the answers to each question listed by either attaching a PDF file and in subsequent
questions identify the appropriate section to review within the PDF, or by answering each of the listed
questions directly inthe text boxes provided. If attaching a PDF file, please indicate the page or
section within the PDF where the answer to each question can be found.

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

[HTML Text]

309.1 Requirement
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.
Means shall be provided to terminate the x ray exposure automatically by either deenergizing the x ray source or
shuttering the x ray beam in the event of equipment failure affecting data collection. Such termination shall occur within
an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a
backup timer or devices which monitor equipment function (1020.33(f)(2)(i)). PDF page numbers:

Means shall be provided to terminate the x ray exposure automatically by either deenergizing the x ray source or
shuttering the x ray beam in the event of equipment failure affecting data collection. Such termination shall occur within
an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a
backup timer or devices which monitor equipment function (1020.33(f)(2)(i)).
[HTML Text]

309.2 Critical Parameters and "Worst Case" Conditions
Note:

For each applicable test listed below, verify thatthe testing adequately reflects the critical
parametersand addresses the "worst case" conditions. As a result of inherentinaccuracies of the test
methods and instrumentation, rejection limits for any test must be sufficiently restrictive to account for
these inaccuracies.

Please note and describe any critical parameters and "worst case" conditions which are unique to your system or test
method. PDF page numbers:

Please note and describe any critical parameters and "worstcase" conditions which are unique to your system or test
method.
[HTML Text]

309.3 Prototype Testing
Note:

For each applicable test listed below, verify thatthe testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testingand/or measuring the parameter for eachmodel with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a singlescan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

309.4 Production Testing
Note:

For each applicable test listed below, verify thatthe testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

309.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

[L]

Page 62 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Are any performance parameters tested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

309.5 Assembler Testing
Note:

For each applicable test listed below, verify thatthe testing adequately reflects the critical
parametersand addresses the "worst case" conditions. As a result of inherent inaccuracies of the test
methods and instrumentation, rejection limits for any test must be sufficiently restrictive to account for
these inaccuracies.

a-i. If test instructionsare provided to the assembler, answer the questions in 309.4 with respect to assembler testing.
Note: The information requested in 309.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 309.4 with respect to assembler testing.
Note: The information requested in 309.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
[HTML Text]

310.0 - Tomographic Plane Location
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

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310.1 Requirement
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result ofinherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

The distance between the indicated location of the tomographic plane or reference plane and its actual location shall not
exceed 5 millimeters(1020.33(g)(3)). PDF page numbers:

The distance between the indicated location of the tomographic plane or reference plane and its actual location shall not
exceed 5 millimeters (1020.33(g)(3)).
[HTML Text]

310.2 Critical Parameters and "Worst Case" Conditions
Note:

Please note and describe any critical parameters and "worst case" conditions which are unique to your system or test
method. PDF page numbers:

Please note and describe any critical parameters and "worst case" conditions which are unique to your system or test
method.
[HTML Text]

310.3 Prototype Testing
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.
a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample
ofcalculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slicethickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample
ofcalculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced bythe nominal tomographic slice thickness.
[HTML Text]

310.4 Production Testing
Note:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
from integration of the dose profile for a single scan or from a direct measurement of the average dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness.
[HTML Text]

310.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

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Details

[HTML Text]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
310.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer the questions in 310.4 with respect to assembler testing.
Note: The information requested in 310.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

311.0 - Illumination Levels of the Light Source...
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

311.1 Requirement
Note:

If a device using a light source is used to satisfy the requirements of paragraph 1020.33(g)(1) &(2), the light source shall
permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of
up to 500 lux (1020.33(g)(5)). PDF page numbers:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
311.2 Critical Parameters and "Worst Case" Conditions
Note:

Please note and describe any critical parameters and "worst case" conditions which are unique to your system or test
method. PDF page numbers:

Please note and describe any critical parameters and "worstcase" conditions which are unique to your system or test
method.
[HTML Text]

311.3 Prototype Testing
Note:

For each applicable test listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions.As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from adirect
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., onethat directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriatesection in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the rawtest data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained fromintegration of the dose profile for a single scan or from adirect
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

311.4 Production Testing
Note:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
instructions for performing each test. Attach as APPENDIX F.e. Identify the instrument(s) used for each test by
manufacturer and model number. Answer the appropriate section in Part 400 foreach instrument(s).f. For each of the
above test methods give the page number of your detailed instructions for performing the test and indicate where the
rejection limits are specified.g. For each of the above test methods, provide sample raw test data.h. If the actual
compliance value is calculated from the raw test data, provide a sample of calculated compliance values complete with
an explanation of any correction factors employed.j. A statement indicating whether the maximum CTDI is obtained
from integration of the dose profile for a single scan or from a direct measurement of the average dose in an interval
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

311.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characetristic (OC) curve (page no)
The average outgoing quality level(AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action taken if the sampling plan leads to a rejection decision.
[HTML Text]

311.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer thequestions in 311.4 with respect to assembler testing.
Note: The information requested in 311.5 (d) (i.e., a copy ofdetailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

a-i. If test instructions are provided to the assembler, answer the questions in 311.4 with respect toassembler testing.
Note: The information requested in 311.5 (d) (i.e., a copy ofdetailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers.
[HTML Text]

312.0 - Shutter Leakage Radiation
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
312.1 Requirement
Note:

For each applicable test listed below, verify that the testing adequately reflectsthe critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

For systems that allow high voltage to be applied to the x ray tube continuously and that control the emission of x rays
with a shutter, the radiation emitted shall not exceed 100 milliroentgens (2.58 x 10 5 coulomb/kilogram) in 1 hour at any
point 5 centimeters outside the external surface of the housing of the scanning mechanism when the shutter is closed.
Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear
dimension greater than 20 centimeters (1020.33(h)(2)). PDF page numbers:

312.2 Critical Parameters and "Worst Case" Conditions
Note:

a. For any test using a scan of the diagnostic source assembly, the rate of scan specified in the test method(s) must
account for the response time of the radiation instrumentation.b. Please note and describe any critical parameters and
"worst case" conditions which are unique to your system or test method. PDF page numbers:

312.3 Prototype Testing
Note:

a. Provide a description of the direct test method (i.e., one thatdirectlymeasures the parameter in question) employed in
testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance valuescomplete with an explanation of any correction factors employed.e. A statement indicating
whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample
ofcalculated compliance valuescomplete with an explanation of anycorrection factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurementof the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

312.4 Production Testing
Note:

312.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

[L]

Page 72 of 81

3627 DX CT Blank Product rpt (OMB 0910-0025)
Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

312.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answerthe questions in 312.4 with respect to assembler testing.
Note: The information requested in 312.5(d) (i.e., acopy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referencedby indicating the appropriate page numbers. PDF
page numbers:
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)

313.0 - Scan Increment Accuracy
Note:

Is this data located in a PDF file?

[L]

Please attach any relevant documents in PDF format that provide answers and explanation for the questions asked in
this section.
[HTML Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

313.1 Requirement
Note:

For each applicabletest listed below, verify that the testing adequately reflects the critical parameters
and addresses the "worst case" conditions. As a result of inherent inaccuracies of the test methods
and instrumentation, rejection limits for any test must be sufficiently restrictive to account for these
inaccuracies.

The deviation of indicated scan increment from actual scan increment shall not exceed 1 mm. Compliance shall be
measured as follows: The determination of the deviation of indicated versus actual scan increment shall be based on
measurements taken with a mass, less than or equal to 100 kilograms, on the patient support device. The patient
support device shall be incremented from a typical starting position to the maximum incrementation distance or 30
centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan
increment may be taken anywhere along this travel (1020.33(i)). PDF page numbers:

The deviation of indicated scan increment from actual scan increment shall not exceed 1 mm. Compliance shall be
measured as follows: The determination of the deviation of indicated versus actual scan increment shall be based on
measurements taken with a mass, less than or equal to 100 kilograms, on the patient support device. The patient
support device shall be incremented from a typical starting position to the maximum incrementation distance or 30
centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicatedscan
increment may be taken anywhere along this travel (1020.33(i)).
[HTML Text]

313.2 Critical Parameters and "Worst Case" Conditions
Note:

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
Please note and describe any critical parameters and "worst case" conditions which are unique to your system or test
method. PDF page numbers:

Please note and describe any critical parameters and "worst case" conditions which are unique toyour system or test
method.
[HTML Text]

313.3 Prototype Testing
Note:

a. Provide a description of the direct test method (i.e., one that directly measures the parameter in question) employed
in testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 for this instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a seriesof 14 scans that are
spaced by the nominal tomographic slice thickness. PDF page numbers:

a. Provide a description ofthe direct test method (i.e., one that directly measuresthe parameter in question) employed in
testing and/or measuring the parameter for each model with respect to this requirement.b. Identify the instrument(s)
used for the test by manufacturer and model number. Answer the appropriate section in Part 400 forthis instrument(s).c.
Provide sample raw test data.d. If the actual compliance value is calculated from the raw test data, provide a sample of
calculated compliance values complete with an explanation of any correction factors employed.e. A statement
indicating whether the maximum CTDI is obtained from integration of the dose profile for a single scan or from a direct
measurement of the average dose in an interval equal to the slice thickness at the center of a series of 14 scans that are
spaced by the nominal tomographic slice thickness.
[HTML Text]

313.4 Production Testing
Note:

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3627 DX CT Blank Product rpt (OMB 0910-0025)
equal to the slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

313.4i Sampling
Is this sampling plan the same as any previous sampling plan?

[L]

Please Attach/Select the appropriate file
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Please indicate the PDF page numbers where the sampling plan is located:
Do you test 100% of the produced models?

[L]

Are any performance parameters tested other than 100%?

[L]

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
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3627 DX CT Blank Product rpt (OMB 0910-0025)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
[HTML Text]
Describe the procedures used for selecting the sample and indicate how randomness is assured.
[HTML Text]
Describe the action takenif the sampling plan leads to a rejection decision.
[HTML Text]

313.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answer the questions in 313.4 with respect to assembler testing.
Note: The information requested in 313.5 (d) (i.e., a copy of detailed instructions for performing each test) should have
already been provided in APPENDIX B and thus may be referenced by indicating the appropriate page numbers. PDF
page numbers:

Section: Part 400 - Common Aspects
401.0 - Instrumentation
Note:

Please provide the answers to each question listed on the following screens in this section (401.1401.4) by either attaching a PDF file and indicating the appropriate section to review within the PDF,
or by answering each of the listed questions directly in the text boxes provided within the template in
screens 401.1 through 401.4. If attaching a PDF file, please indicate the page or section within the
PDF where the answer to each question can be found.

401.1 - Radiation Measurement
Item: 1 (could contain up to 10 items with none required)
Note:

Is this data located in a PDF file?
Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

[L]

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Attach only one PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Manufacturer and Model Number if CommerciallyAvailable, PDF page numbers:
Type of Instrument, PDF page numbers:
Precision, PDF page numbers:
Accuracy, PDF page numbers:
Response Time, PDF page numbers:
Energy Dependence, PDF page numbers:
Angular Response, PDF page numbers:
Exposure Rate Dependence, PDF page numbers:
Ranges, PDF page numbers:
Effective Measurement Area, PDF page numbers:
Describe the proceduresused for calibration of each instrument including the
interval of time between calibrations. PDF page numbers:
How do you assure proper day to day operation of each instrument? PDF page
numbers:
Manufacturer and Model Number if Commercially Available
Type of Instrument
Precision
Accuracy
Response Time
Energy Dependence
Angular Response
Exposure Rate Dependence
Ranges
Effective Measurement Area
Describe the procedures used for calibration of each instrument including the interval of time between calibrations.
[HTML Text]
How do you assure proper day to day operation of each instrument?
[HTML Text]

401.2 - Illuminance
Item: 1 (could contain up to 10 items with none required)

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Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Note:

Is this data located in a PDF file?

[L]

Attach only one PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Manufacturer and Model Number if the Instrument is Commercially Available, PDF
page numbers:
Type of Instrument, PDF page numbers:
Precision, PDF page numbers:
Accuracy, PDF page numbers:
Ranges, PDF page numbers:
Describe the procedures used for calibration of each instrument including the
interval of time between calibrations. PDF page numbers:
How do you assure proper day to day operation of each instrument? PDF page
numbers:
Manufacturer and Model Number if the Instrument is Commercially Available
Type of Instrument
Precision
Accuracy
Ranges
Describe the procedures used for calibration of each instrument including the interval of time between calibrations.
[HTML Text]
How do you assure proper day to day operation of each instrument?
[HTML Text]

401.3 - Electrical Measurement
Item: 1 (could contain up to 10 items with none required)
Note:

Is this data located in a PDF file?

[L]

Attach only one PDF file here.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

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Created By: eSubmitter on 6/10/2013 at 3:06 PM

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3627 DX CT Blank Product rpt (OMB 0910-0025)
Details

[HTML Text]

Type of Instrument, PDF page numbers:
Manufacturer and Model Number if the Instrument is Commercially Available, PDF
page numbers:
Rated Accuracy, PDF page numbers:
Precision, PDF page numbers:
Ranges, PDF page numbers:
Response Time, PDF page numbers:
Describe the procedures used for calibration of each instrument including the
interval of time between calibrations. PDF page numbers:
Show where each instrument listed is connected during testing with the use of
schematic diagrams. PDF page numbers:
Type of Instrument
Manufacturer and Model Number if the Instrument is Commercially Available
Rated Accuracy
Precision
Ranges
Response Time
Describe the procedures used for calibration of each instrument including the interval of time between calibrations.
[HTML Text]
Show where each instrument listed is connected during testing with the use of schematic diagrams. Pages:
[HTML Text]

401.4 - Other Measurements
Item: 1 (could contain up to 10 items with none required)
Note:

Is this data located in a PDF file?

[L]

Attach only one PDF file here.
File Attachment

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Details

[HTML Text]

Type of Instrument, PDF page numbers:

[L]

Manufacturer and Model Number if the Instrument is Commercially Available, PDF
page numbers:
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3627 DX CT Blank Product rpt (OMB 0910-0025)
Rated Accuracy, PDF page numbers:
Precision, PDF page numbers:
Ranges, PDF page numbers:
If any number of commercially available instruments with certain basic
characteristics may be used, it is sufficient to state the minimum accuracy, precision
ranges, and so forth, of the class of instruments that will be used. If any instrument
is unique or of special manufacture, however, then the manufacturer and model
number should be stated. PDF page numbers:
Describe the procedures used for calibration of each instrument including the
interval of time between calibrations. PDF page numbers:
Type of Instrument
Manufacturer and Model Number if the Instrument is Commercially Available
Rated Accuracy
Precision
Ranges
If any number of commercially available instruments with certain basic characteristics may be used, it is sufficient to
state the minimum accuracy, precision ranges, and so forth, of the class of instruments that will be used. If any
instrument is unique or of special manufacture, however, then the manufacturer and model number should be stated.
[HTML Text]
Describe the procedures used for calibration of each instrument including the interval of time between calibrations.
[HTML Text]
Stop:

You have reached the end of this report. Please verify that all PDFs that are to be included in this
submission are correctly attached to a specific file attachment question. Otherwise, they will not be
packaged with your report. Check to make sure you have no missing data (select Missing Data
Report from the Output menu). Once you have confirmed that there is no missing data and all your
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Message:

Form FDA 3627 Diagnostic X-Ray CT Products Radiation Safety Report (10/31/2013)

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.
Created By: eSubmitter on 6/10/2013 at 3:06 PM

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File Type	application/pdf
File Modified	2013-06-10
File Created	2013-06-10