FDA 3626 Diagnostic X-Ray (esubmitter)

Reporting and Recordkeeping for Electronic Products - General Requirements

3626 DX Product Report

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⚠️ Notice: This form may be outdated.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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Submission Report

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Submission Report
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

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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/RadiationEmittingProducts/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).
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. The OMB control number for
this information collection is 0910-0025 (expires January 31, 2017).
Role
What is your role?
Information:

!* Manufacturer

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
Step 1

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.)

What Type of Submission is this? (Supplements should be submitted
selecting the same document type as the original report.)

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!* (•) 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

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( ) Variance Request
(General, not Laser Light
Show) (21 CFR 1010.4)
( ) Laser Original
Equipment/Component
Manufacturer Registration
(21 CFR 1040.10(a)(3)(ii))
( ) Abbreviated Report
(21 CFR 1002.12)
Step 2

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.

What Type of Product is this Radiation Safety Report about?

Diagnostic X-Ray Systems and Major Components
What Type of Product is this Annual Report about?
What Laser Light Show Document are you filing?
What Type of Correspondence is this?
What Type of Product is this Variance Request about?

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Manufacturer Data
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:

Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

Responsible Individual
Note:

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

Select the Responsible Individual from the Contact Address book:

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number

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Mailing Location:
Address
Telephone Number
Fax Number

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:

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

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:

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name

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Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number
Comments:
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

Select the Parent Establishment and Contact from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

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?

Importer

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Additional Manufacturing Locations

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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 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
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.
Category
Product Code
Performance
Standard
If Other, provide a category name for this specific product.

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Report Information
Is this the first time you've submitted a report on the particular type of product selected
in the Product Type 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?
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?
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

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?

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

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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?

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

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

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 "Followup correspondence to FDA."

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

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:
Details

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)?

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

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

Request for approval of alternate labeling?

Application for alternate test procedures (21 CFR 1010.13)?

You may provide an explanation and/or attach any relevant documents here:

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.

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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.
Item

No Information Provided.

Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details
Stop:

For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission
instructions 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:
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
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
Does this document or any of its attachments contain:
A response to an FDA inspection?

What was the date of the inspection?
A response to a Warning letter or a Notification of Noncompliance or Defect from the
FDA?

What was the date of the Warning Letter or other notification letter?
A response to a report review inquiry from the CDRH (the inquiry may have been in the
form of a letter, email, or phone call)?

What was the date of the inquiry?
A response to any other communication from FDA?

What was the date of the communication?
Provide an explanation:

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!

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Is there any other relevant information or additional comments that would help expedite the review of this
submission? Click the plus sign below to attach any supporting files.
Details

Private Labeling
Is the product sold by other companies under different brand names?

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.

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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Product & Model ID
2.4 MODEL DESIGNATION
Give the model designation for any components (including combination components) that are being
certified in this report. Also, provide the model designation for each combination that is being certified in
this report. Do not list components which are not being certified by this report. For all components
certified by this report and its supplements identify the model exactly as it appears on the identification
label. If reporting a model family, provide the model designation of each model. If you do not have a
model family or brand name, leave the field blank.
Item

Model Name

Family Name

Brand Name

2.4.1 MODEL TYPE DESIGNATION
2.5 INDIVISIBLE COMBINATION OF COMPONENTS
Do you combine components under a single certification label pursuant to 21 CFR 1020.30(c)?

2.5.1 COMBINATION OF COMPONENTS
2.6 OTHER NAMES OR LABELS
Are any of the models you manufacture reported in 2.4 and/or 2.5 sold under name(s) other than the
certifying manufacturer?

2.6.1 Names or Labels
2.7 LABEL DESCRIPTION
Note:

For every model listed under 2.4, 2.5 and 2.6, provide an exact replica of all labels filled out
as they would be when introduced into commerce. Attach copies of the labels and the
requested information. The label should include the following as applicable:

1. The certification statement
2. The name and address of the manufacturer (or the individual or company under whose name it
is sold)
3. The date and place of manufacture. If the place of manufacturer is not the address in item 2
above, then the code used on the label to identify the location of manufacture as listed under
1.8
4. The model designation and sample serial number
5. The manufacturer, model designation and sample serial number of the tube insert if applicable
6. In addition, the standard requires that the labels be permanently affixed, legible, and
accessible to view when the product is fully assembled for use.Provide a drawing or

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photograph of each certifiable component and/or combination showing where the attached
label is located.
Attach a file that contains a replica of labels for every model listed under 2.4, 2.5 and 2.6. Click on the plus
sign below to attach files.

2.8 Part 1: COMPLETE SYSTEMS AND SUBSYSTEMS
Are there components certified by this report marketed by you as a system or subsystem of components?

2.8 PART 2: COMPLETE SYSTEMS AND SUBSYSTEMS
2.9 ASSEMBLER INFORMATION
Note:

Attach "Information to Assembers" (1020.30 (g)) as a separate file. Include each of the
following as separate files: (a.) Assembly and testing instructions necessary for assuring
compliance to the Performance Standard and (b.) Compatibility specifications referenced in
21 CFR 1020.30(g).

Attach Compatibility Specifications referenced in 21 CFR 1020.30 (g) as a separate file.
Details
Are there assembly and testing instructions necessary at the installation site for assuring compliance to the
federal standards?
Attach Assembly and Testing Instructions necessary for assuring compliance to the Performance Standard as
a separate file.
Details
Note:

If no acts by the assembler will cause failure to comply with the federal standards and all that
is necessary is to plug the system in to an adequate power socket, then theuser manual
should specify that no assembly instructions or testing is necessary for compliant use of the
equipment other than proper power connection. As such no assembly manual will be
needed.

2.10 USER INFORMATION
Note:

Attach "Information to Users" (1020.30(h)) as separate files. (PDF searchable files are
acceptable.) Include each of the following as a separate file:

(a.) Operating Instructions
(b.) Maintenance Schedule
(c.) Picture or drawing of product
(d.) Product Specifications and Tolerances
(e.) Cautionary Statements for 21 CFR 1020.32(a)(1) and (f) if applicable
(f.) Leakage Technique Factors and Tube Rating Charts if applicable
Attach for each model, system or subsystem (as appropriate) the above information in a separate file. Click
on the plus sign below to attach any supporting files.

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2.11 ADDITIONAL INFORMATION
2.11.1 BEAM LIMITING DEVICE (BLD)
Is this report intended for the certification of a beam limiting device (either seperately or in combination)?

Use and Type of Collimation
2.11.2 HV GENERATOR
Is this report intended for the certification of an x-ray high voltage generator (either separately or in
combination)?

Use and Type
2.11.3 X-RAY CONTROL
Is this report intended for the certification of an x-ray control (either separately or in combination)?

Use, Maximum kVp, and Fluoroscopic Control
Maximum Deviation from Indicated Value
For each model x-ray control certified in this report, list in an attached table, maximum deviation from
the indicated value as given in the user technical specifications (models with identical specifications
may be grouped together).
Click on the plus sign below to attach the appropriate files.

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Component Description
201.0 TUBE HOUSING ASSEMBLY
Note:

This section should be completed for each tube housing assembly listed in section 2.4 and
any combination listed in section 2.5 that contains a tube housing assembly as an integral
partthereof.

Is this report intended for the certification of a tube housing assembly or combination containing a tube
housing assembly?

201.1 Tube Housing Assembly Information
202.0 BEAM-LIMITING DEVICES
Is this report intended for the certification of a beam limiting device or combination containing a beam
limiting device?
Is the beam limiting device designed for intraoral dental?

202.1 Dental BLD (intraoral)
202.2 Part 1: General Purpose Radiographic BLD
General Purpose Radiographic BLD - mobile and stationary (excluding mammographic, spot-film
devices, and dental units)
Is the BLD designed for general purpose radiography?
Are any beam-limiting device(s) equipped with a light localizer?

202.2 Part 2: General Purpose Radiographic BLD
202.3 Part 1: Stationary General Purpose Radiographic
Are any model BLDs designed as a Stationary General Purpose Radiographic BLD?
Are any of the reported BLD models you are certifing designed for positive beam
limitation (PBL)?

202.3 Part 2: Stationary General Purpose Radiographic BLD
202.4 Part 1: Beam Limiting Device used with Spot Film
Is the beam-limiting device designed to be used with Spot Film Radiography or Digital Spot Recording?

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202.4 Part 2: Beam Limiting Device used with Spot Film
202.5 Part 1: Beam Limiting Device used for Fluoroscopy
Is the BLD designed for fluoroscopy use?
Are any of the beam-limiting device(s) designed for use in image-intensified fluoroscopy, other than
radiation therapy simulation?

202.5 Part 2: Beam Limiting Device used for Fluoroscopy
202.6 Part 1: X-Ray Systems Designed for One SID
Is the BLD designed to be used with systems with one SID and one Image receptor size?
Do any of the beam-limiting devices have a light field that defines the perimeter of the x-ray field?
Are any of the beam-limiting devices designed for fixed SID/image receptor size?

202.6 Part 2: X-Ray Systems Designed for One SID
202.7 Part 1: Beam Limiting Devices Designed for Mammography
Is the BLD designed for mammography?
Does the beam-limiting device have a light field that defines the perimeter of the x-ray field?

202.7 Part 2: Beam Limiting Devices Designed for Mammography
202.8 Part 1: Other Radiographic X-Ray Systems
Is the BLD designed for other radiographic systems?
Does the beam-limiting device have a light field that defines the perimeter of the x-ray field?
Does the x-ray field extend beyond the edge of the image receptor?

202.8 Part 2: Other Radiographic X-Ray Systems
202.9 Part 1: Variable Filtration
Does the beam-limiting device have variable filtration selection?

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202.9 Part 2: Variable Filtration
202.10 Capacitor Storage X-Ray Systems
Is any model beam-limiting device intended to be used on capacitor storage x-ray systems?
List each model that is designed for capacitor storage units.
Item

No Information Provided.

203.0 X-RAY CONTROLS
Is this report intended for the certification of an x-ray control or combination containing an x-ray control?

203.1 Warning Label
Provide a replica of the warning label affixed to the control panel and specify where the label is located with
respect to the main power switch.

203.2 Part 1: Battery Powered Generator
Is the x-ray control used with a battery powered generator?

203.2 Part 2: Battery Powered Generator
203.3 Part 1: Radiography
Radiography (x-ray controls used for radiography, i.e., recording of static images viewed after
termination of exposure)
Is the x-ray control designed to operate in the radiographic mode?

203.3 Part 2: Radiography
203.4 Part 1: Fluoroscopy
Fluoroscopy (x-ray controls used for generating x-ray images instantaneously and continuously to
display dynamic procedures)
Is the x-ray control designed to operate in the fluoroscopic mode?

203.4 Part 2: Fluoroscopy

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204.0 HIGH VOLTAGE GENERATORS
Note:

This item should be completed for each high-voltage generator listed in section 2.4 and any
combination listed in section 2.5 that contains a high-voltage generator as an integral part
thereof. If this report is not certifying a high-voltage generator then go to section 205.0

Is this report intended for the certification of an x-ray high-voltage generator of combination containing an
x-ray high-voltage generator?
Do any model high-voltage generators contain a thermionic diode valve?
List each model that has a thermionic diode.
Item

No Information Provided.

205.0 SPOT FILM DEVICES AND IMAGE INTENSIFIERS
Note:

This section should be completed for each conventional spot-film device and image
intensifier listed in section 2.4 and any combination listed in section 2.5 that contains such
components as an integral part thereof. If this report is not certifying a spot film device or
image intensifier then go to section 206.0

Is this report intended for the certification fo a spot film device or combination containing a spot film device?

205.1 Spot Film Device
205.2 Technique Factor Adjustment
205.3 Part 1: Image Intensifier
Is this report intended for the certification of an image intensifier or combination containing an image
intensifier?

205.3 Part 2: Image Intensifier
206.0 TABLES, CASSETTE HOLDERS, FILM CHANGERS AND CRADLES
Note:

This section should be completed for each table, cassette holder*, film changer and/or cradle
listed in section 2.4 and any combination listed in section 2.5 that contains such components
as an integral part thereof. If this report is not certifying a table, cassette holder, film changer
and/or cradle then go to section 207.0* Applicable only to cassette holders that are intended
for permanent verticle mounting and/or contain a front panel.

Is this report intended for the certification of a cassette holder, film changer, x-ray table, and/or a cradle?

206.1 Subject Component Capabilities
Do any of thesubject components allow for operator adjustment of technique factors?
Do any of the subject components provide limit switches that automatically preempt the preset exposure
time of the master control panel?

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Message:

If "Yes" has been selected for either of the above questions, the following note applies:

Note:

Since the relative component controls x-ray output, it is considered an x-ray control and you
must address applicable questions in section 203.0, PART 200. Section 2.5.1 should list the
combination of appropriate component and x-ray control.

206.2 Part 1: Model Film Changer
Is this report for the certification of a film changer?

206.2 Part 2: Model Film Changer
206.3 X-Ray Tables
Is this report for the certification of an x-ray table?

206.4 Model X-Ray Table Characteristics
206.5 Verticle Cassette Holder
Is this report for the certification of a verticle cassette holder?
For each model verticle cassette is the verticle cassette holder equipped with cassette size sensors?

206.6 Image Receptor Sizes
207.0 CEPHALOMETRIC DEVICES
Note:

This section should be completed for eachcephalometric device listed in section 2.4. If this
report is not certifying a cephalometric device then go to section 208.0

Is this report intended for the certification of the cephalometric device?

207.1 Cephalometric Device Including a Beam-Limiting Device
207.2 Cephalometric Device Including a Cassette Holder
208.0 IMAGE RECEPTOR SUPPORT DEVICES FOR MAMMOGRAPHIC X-RAY
SYSTEMS
Note:

This section should be completed for each image receptor support device listed in section
2.4. If this report is not certifying a image receptor support device then go to section 300.0

Is this report intended for the certification of a image receptor support device?

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208.1 Cassette Holder with Front Panel
Does the image receptor support device include a cassette holder with a front panel as an integral part?

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Quality Control Testing
301.0 Leakage Radiation from the Diagnostic Source
Note:

Answer the following questions if certifying a beam-limiting device or tube housing assembly
in this submission (i.e., if yes was selected for question 2.4 (a),(b), 2.5 (a), (b), (c) or (d)).

Requirement:
Message:

The leakage radiation from the diagnostic source assembly measured at a distance of 1
meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (vice
100 milliroentgens (mR) exposure) 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)).

Applicability:
Message:

This requirement is applicable to the diagnostic source assembly (tube housing assembly
combined with a beam-limiting device). Similar models of a single component type may be
grouped for presentation of test results applicable to this requirement when the technical
basis for this grouping is clearly stated in the description of prototype testing (see Prototype
Testing (a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

The test results must include data representative of each compatible combination of
tube housing assembly and beam-limiting device.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

C. Message:

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.

D. Message:

For any test using a scan of the diagnostic source assembly, the rate of scan specified
in the test methods) must account for the response time of the radiation instrumentation.

Prototype Testing:
This section is for start up prior to full production phase and thus the testing and quality control procedures
may not be the same as production testing. Does prototype testing apply?
A.

Describe the direct test method (i.e., one that actuallymeasures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliancevalue calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.

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Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Production Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliancevalues complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as anattachment for documentation.
Details

Identify the instrument(s) used for each test by manufacturer and model number.

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Details
G. For each test method listed in question (B.) under Assembler Testing, attach the detailedinstructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

Provide a copy of the pages in the user manual that specifies no assembly or installation instructions are
necessary and all that is needed to operate the system is to plug the power cord into the wall socket.
Details

302.0 Beam Quality
Note:

Answer the following questions if certifying a beam-limiting device or tube housing assembly
in this submission (i.e., if yes was selected for question 2.4 (a), (b), 2.5 (a), (b), (c) or (d)).

Requirement:
Message:

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)).

Applicability:
Message:

This requirement is applicable to the tube housing assembly or the diagnostic source
assembly if the beam-limiting device containsfiltration. Similar models of a single component
type may be grouped for presentation of test results applicable to this requirement when the
technical basis for this grouping is clearly stated (see (a) under Prototype Testing).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

The test results must include data representative of each compatible combination of
tubehousing assembly and beam-limiting device.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

C. Message:

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.

D. Message:

To minimize the sources of scatter radiation, the x-rayfield specified in the test method
(s) must be just large enough to cover the sensitive volume of the detector.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?

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Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Production Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. Foreach test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed intesting of each model with respect to this requirement. If reference is
made to a test protocol document,provide a copy as an attachment for documentation.
Details

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Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Assembler Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

303.0 Aluminum Equivalence
Note:

Answer the following questions ifcertifying a cassette holder with a front panel or the device
you are certifying includes a cassette holder as an integral part (i.e., if yes was selected for
question 2.4 (l), 207.2, or 208.1).

Requirement:
Message:

The aluminum equivalent of the frontpanels of cassette holders and film changers, tabletops,
and cradles that are used between the patient and image receptorshall not exceed the limits
indicated in Table II of the diagnostic x-ray standard (see 1020.30(n)).

Applicability:
Message:

This requirement is applicable to cassetteholders, film hangers, tables and cradles. Similar
models of a single component type may be groupedfor. presentation of test results
applicable to this requirement when the technical basis for this grouping is clearly stated in
the description of prototype testing (see 303.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

Since the peak tube potential has a critical effect on determining the aluminum
equivalent, the test method(s) must provide the procedurefor periodic calibration of tube
potential.

C. Message:

Since compliance will be measured at 100 kVp and 2.7 millimeters of aluminum halfvalue layer, test data resulting from other conditions must be extrapolated to the value at
the specified conditions.

Describe the direct testmethod (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

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Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indicationof compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percentof the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

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Describe all methods employed in testing of each model with respect to this requirement. If reference is
madeto a test protocol document, provide a copy as an attachment for documentation.
Details
C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indicationof compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailedinstructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

304.0 Standby Radiation from Capacitor Energy Storage Equipment
Requirement:
Message:

Radiation emitted from the x-ray tube when the exposure switch or timer is not activated
shall not exceed a rate of 0.26 micrograysor 0.03 mR in 1 minute at 5 centimeters from any
accessible surface of the diagnostic source assembly, with the beam-limiting device fully
open and 0.88 mGy or 100 mR in1 hour 100 centimeters from the source (see 1020.31(l)).

Applicability:
Message:

This requirement is applicable to the diagnostic source assembly of capacitor energy storage
equipment. Similar models of a single component type may be grouped for presentation of
test results applicable to this requirement when the technical basis for this grouping is clearly
stated in the description of prototype testing (see 304.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

The test results must include data representative of each compatible combination of
tube housing assembly and beam-limiting device.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

C. Message:

To test for the maximum standby radiation, the beam-limiting device must be fully open
and the highest available peak tube potential must be used. These conditions must
bespecified in the test method(s).

D. Message:

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For any test using a scan of the diagnostic source assembly, the rate of scan specified
in the test method(s) must take into account the response time of the radiation
instrument.
Prototype Testing:
This section is for start up prior to full production phase and thus the testing and quality control procedures
may not be the same as production testing. Does prototype testing apply?
A.

Describe the directtest method (i.e., one that actually measures x radiation) employedin testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, providea copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of
anycorrection factors employed.
Details

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Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurateindication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach acopy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated fromthe raw test data?

305.0 Fuoroscopic Entrance Exposure Rate
Requirement:
1.

Message:

Fluoroscopic equipment manufactured prior to May 19,1995.

Message:

Equipment with automatic exposure rate control shall not be operable at any
combination of tube potential and current that will result in am exposure rate in
excess of 2.58x 10-3 C/kg per minute or 10 roentgens per minute at the point where
the center of the useful beam entersthe patient, except:(a) during recording of
fluoroscopic images, or(b)when an optional high-level control is provided. When so
provided, the equipment shall not be operable at any combination of tube potential
and current that will result in an exposure rate in excess of 1.29x 10-3 C/kg per
minute (5 R/min) at the point where the center of the useful beam enters the ???

Message:

Fluoroscopic equipment that is not provided with automatic exposure rate control
shall not be operable at any combination of tube potential and current that will result
in an exposure rate in excess of 1.29x 10-3 C/kg per minute (5 R/min) at the point

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where the center of the usefulbeam enters the patient, except:(a) during recording
of fluoroscopic images, or(b) when an optional high-level control isactivated (see
1020.32(d)).
C.

Message:

Fluoroscopic equipment that is provided with both automatic exposure rate control
and manual control shall not be operable at any combination of tube potential and
current that will result in an exposure rate in excess of 1.29x 10-3 C/kg per minute
(5 R/min) in the mode containing high-level control and 2.58x 10-3 C/kg per minute
or 10 roentgens per minute at the point where the center of theuseful beam enters
the patient, except:(a) during recording of fluoroscopic images, or(b) when an
optional high-level control is activated (see 1020.32(d)).(c) when a mode without
high level option is activated in which case the exposure rate is limited to 2.58x 10-3
C/kg per minuteor 10 roentgens per minute at the point where the center of the
useful beam enters the patient.
Fluoroscopic equipment manufactured on or after May 19,1995.

Message:

Equipment which can operate above 44 mGy/min (5 R/min) must have automatic
exposure rate control.

Message:

Equipment shall not be operable at any combination of tube potential and current
that will result in an air kerma rate (AKR) in excess of 88 mGy/min or 10 roentgens
per minute at the point where the center of the usefulbeam enters the patient,
except:(a) during recording of fluoroscopic images, or(b) when an optional high-level
control (HLC) is activated. When theHLC is activated, it shall not be operable at any
combination of tube potential and current that will result in an exposure rate in
excess of 176 mGy/min or 20 roentgens per minute at the point where the center of
the useful beam enters the patient unless the high-level control is activated.

Applicability:
Message:

This requirement is applicable to fluoroscopic and automatic exposure rate x-ray controls.
Similar models of a single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is clearly stated in
the description of prototype testing (see 305.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies ofthe test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

To test for the maximum entrance exposure rate, the beam-limiting device must be fully
open. This condition must be specified in the test method(s).

C. Message:

For equipment without automatic exposure rate control, the test results must include
data for "worst case" combinations of peak tube potentials and tube currents (e.g.,
maximum kVp and mA).

D. Message:

For equipment with automatic exposure rate control, the technique factors specified in
the test method(s) must be driven tothe maximum design limits for this test.

For automatic exposure rate control equipment using direct viewing optics, the test must
be performed with suppressed ambient light conditions.

Message:

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

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C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete withan explanation of any
correctionfactors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement.If reference is
made to a test protocol document, provide a copy as an attachment for documentation.

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Details
C. If any test used to monitor compliance doesnot actually measure xradiation, explain why it is an accurate
indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

306.0 Primary Protective Barrier Transmission
307.0 Reproducibility and Linearity
Requirement:
Message:

Whenthe x-ray unit is operated on an adequate power supply as specified by the
manufacturer;(1) the estimated coefficient of variation of radiation exposure shall not be
greater than 0.05 for any specific combination of technique factors, and where: s=Estimated
standard deviation X = Mean value of the sample Xi = ith observation of the sample N = the
number of observations sampled(2) the average ratios of exposure to the indicated tube
current exposure time product (mAs) obtained at any two consecutive tube current
settingsshall not differ by more than 0.10 times their sum, or where X1 and X2 = the average
mR/mAs values obtained at each of two consecutive tube current settings. (see 1020.31(b)
and (c)).

Applicability:
Message:

This requirement is applicable to radiographic x-ray controls and high-voltage generators.
Similar models of a single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is clearly stated in
the description of prototype testing (see 307.4(a)).

Critical Parameters and "Worst Case"Conditions:
A.

Message:

As a result of inherent inaccuracies of the test methodand instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

To assure compliance with the reproducibility and linearity requirements, the test results
must include data for "worst case" combinations of technique factors and supplyline

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conditions (e.g., low kVp,high mA, low-line voltage, and highest allowed line-voltage
regulation).
C. Message:

To determine compliance, variable controls for technique factors shall be adjusted to
alternate settings and reset to the test setting between measurements.

Prototype Testing:
This section is for startup prior to full production phase and thus the testing and quality control procedures
may not be the same as production testing. Does prototype testing apply?
A.

Describe the directtest method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testingof each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Production Testing,attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

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Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details
Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copyas an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measurex radiation, explain why it is an accurate
indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturerand model number.
Details

G. For each test method listed in question (B.) under Assembler Testing, attach the detailed instructions for
performing thetest where the rejection limits are specified.
Details
H. For each test method listed inquestion (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

Providea copy of the pages in the user manual that specifies no assembly or installation instructions are
necessary and all that is needed to operate the system is to plug the power cord into the wall socket.

308.0 Radiation from Components other than the Diagnostic Source Assembly
309.0 Peak Tube Potential
Requirement:
Message:

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

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power supply as specified by the manufacturer. The deviation of the peak tube potential shall
not exceed the limits given (see 1020.31(a)(4) and 1020.32(f)).
Applicability:
Message:

This requirement is applicable to fluoroscopic and radiographic x-ray controls and highvoltage generators. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technicalbasis for this
grouping is clearly stated in the description of prototype testing (see 309.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

To assure compliance with the maximum deviation statements provided to the user, the
testresults must include data for "worst case" combinations of technique factors and
supply line conditions (e.g., highest kW, low line voltage, and highest allowed linevoltage regulation).

Prototype Testing:
This section is for start up prior to full production phase and thus the testing and quality control procedures
maynot be the same as production testing. Does prototype testing apply?
A.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each modelwith respect to this requirement.

Identify theinstrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.

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Details
G. For each test method listed in question (B.) under Production Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does thetest involve a direct test of the performance parameter?
B.

Describe all methods employed in testingof each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachmentfor documentation.
Details

C. If any test used to monitor compliance doesnot actually measure x radiation, explain why it is an accurate
indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

310.0 Tube Current
Requirement:

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The manufacturer shall state themaximum deviation ofthe 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 1020.31(a)(4) and 1020.32(f)).

Applicability:
Message:

This requirement is applicable to fluoroscopic and radiographic x-ray controls and highvoltage generators. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical basis for this
groupings clearly stated in the description of prototype testing (see 310.4(a)).

Critical Parameters and "WorstCase" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

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, low-line voltage, and highest allowed linevoltage regulation).

Prototype Testing:
This section is for start up prior to full production phase and thus the testing and quality control procedures
may not be the same asproduction testing. Does prototype testing apply?
A.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does notactually measure x radiation, explain why it is an accurate
indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test inquestion (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.

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Details
F.

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve adirect test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing eachtest.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

311.0 Tube Current - Exposure Time Product

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Requirement:
Message:

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 (see1020.31(a)(4)).

Applicability:
Message:

This requirement is applicable to radiographic x-ray controls andhigh voltage generators that
have mAs settings. Similar models of a single component type may be grouped for
presentation of test results applicable to this requirement when the technical basis for this
grouping is clearly stated in the description of prototype testing (see 311.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

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, low line voltage, and highest allowed linevoltage regulation).

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made toa test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain whyit is an accurate
indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test inquestion (C.)

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Details
E.

Attach a copy ofthe detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete withan explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indication of compliance with this requirement.
D. Submitthe technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

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Details

312.0 Exposure Time
Requirement:
Message:

The manufacturer shall state the maximum deviation of the exposure time from its
preindicated value during an exposure, when the equipment is connected to an adequate
power supply as specifiedby the manufacturer. The deviation of exposure time shall not
exceed the limits given (see 1020.31(a)(4)).

Applicability:
Message:

This requirement is applicable toradiographic x-raycontrols and high-voltage generators.
Similarmodels of a single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is clearly stated in
the description of prototype testing (see 312.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

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, low-line voltage, and highest allowed linevoltage regulation).

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer andmodel number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance doesnot actually measure x radiation, explain why it is an accurate
indication of compliance with this requirement.

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D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Assembler Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question(B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

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313.0 Automatic Exposure Control Limits
Requirement:
Message:

Either the product of peak x-ray tubepotential, current, and exposure time shall be limited to
not more than 60 kWs per exposure or the product of xray tube current and exposure time
shall be limited to not more than 600 mAs per exposure except when the x-ray tube potential
is less than 50 kVp in which case the product of x-ray tube current and exposure time shall
be limited to not more than 2000 mAs per exposure (see 1020.31(a)(3)(iii)).

Applicability:
Message:

This requirement is applicable to radiographic x-ray controls and high voltage generators
used in systems with automatic exposure controls. Similar models of a single component
type may be groupedfor presentation of test results applicable to this requirement when the
technical basis for this grouping is clearly stated in the description of prototype testing (see
313.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

To assure compliance with the 60 kWs, 600 mAs, or 2000 mAs limits applicable to this
system, the test results must include data for various combinations of technique factors.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respectto this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

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Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Production Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each testmethod listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does thetest involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect tothis requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain why itis an accurate
indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

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Details
I.

Is the actual compliance value calculated from the raw test data?

314.0 Automatic Exposure Control Minimum Exposure Time
Requirement:
Message:

When the x-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time
for field emission equipment rated for pulsed operation shall be equalto or less than a time
interval equivalent to two pulses, andthe minimum exposure time for all other equipment
shall be equal to or less than 1/60second or a time interval required to deliver 5 mAs,
whichever is greater (see 1020.31(a)(3)(ii)).

Applicability:
Message:

This requirement is applicable to radiographic x-ray controls and high-voltage generators
used in systems with automatic exposure controls. Similar models of a single component
type may be grouped for presentation of test results applicable to this requirement when
thetechnical basis for this grouping is clearly stated in the description of prototype testing
(see 314.4(a)).

Critical Parameters and "Worst Case" Conditions:
Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits
for any test must be sufficiently restrictive to assure compliance with the standard.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made toa test protocol document, provide a copy as an attachment for documentation.

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Details
C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment fordocumentation.
Details

C. If any test used to monitor compliance does not actuallymeasure x radiation, explain why it is an accurate
indication of compliancewith this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.) under Assembler Testing, attach the detailed instructions
forperforming the test where the rejection limits are specified.
Details

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H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

315.0 Illuminance of Light Localizers
Requirement:
Message:

When a light localizer is used to define the perimeter of the x-ray field, it shall provide an
average illumination of not less than 160 lux (15 footcandles) at 100 centimeters or at the
maximum SID whichever is less. The average illumination shall be based upon
measurements madein the approximate center of each quadrantof the light field (see
1020.31(d)(2)(ii) and (f)(4)(i)).

Applicability:
Message:

This requirement is applicable to any beam-limiting devices in a general purpose or other
radiographic system that uses a light localizer to define the perimeter of the x-ray field.
Similar models of a single component type may be grouped for presentation of test results
applicableto this requirement when the technical basis for this grouping is clearly stated in
the description of prototype testing (see (a) under Prototype Testing).

Critical Parameters and "Worst Case" Conditions:
Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection limits
for any test must be sufficiently restrictive to assure compliance with the standard.

PrototypeTesting:
This section is for start up prior to full production phase and thus the testing and quality control procedures
may not be the same as production testing. Does prototype testing apply?
A.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) used for thetest by manufacturer and model number.

C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

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Describeall methods employed in testing of each model with respect to this requirement. If referenceis
made to a test protocol document, provide a copy as an attachment for documentation.
Details
C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indication of compliance with this requirement.
D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturerand model number.
Details

G. For each test method listed in question (B.) under Assembler Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.

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Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

316.0 Alignment of Visually Defined X-Ray Fields
Requirement:
A.

Message:

Visual fields (including light fields): Means shall be provided for visually defining the
perimeter of the x-ray field for all general purpose x-ray systems. The total misalignment
of the edges of the visually defined field with the respective edges of the x-ray field along
either the length or width of the visually defined field shall not exceed 2 percent ofthe
distance from the source to the center of the visually defined field when the surface upon
which it appears is perpendicular to the axis of the x-ray beam (see 1020.31(d)(2)(i)).

Message:

Light fields: The edge of the light field at 100 centimeters or at themaximum SID,
whichever is less, shall have a contrast ratio, corrected forambient lighting, of not less
than 4 in the case of beam-limiting devices designed for use on stationary general
purpose equipment,and a contrast ratio of not less than 3 in the case of beam-limiting
devices designed for use on mobilegeneralpurpose and other radiographic equipment
(see 1020.31(d)(2)(iii) and (f)(4)(i)).

Applicability:
Message:

This requirement is applicable to any beam-limiting device in a general purpose or other
radiographic system that uses a light localizer to define the perimeter of the x-ray field.
Similar models of a single component type may be grouped for presentation of test results
applicable to this requirement when the technical basis for this grouping is clearly stated in
the description of prototype testing (see (b) under Prototype Testing).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the testmethod and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

To assure compliance with the requirement for visually defining the perimeter of the
x-ray field, the test results must include data for the range of SID's and image receptor
sizes.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each model with respect to this requirement.

Identify the instrument(s) usedfor the test by manufacturer and model number.

C. Attach asample of raw test data.
Details

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D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation ofany correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed intesting of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attacha copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from theraw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Isthis performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

C. If any test used to monitor compliance does not actually measure x radiation, explain whyit is an accurate
indication of compliance with this requirement.

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D. Submit the technical data that supports the use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

G. For each test method listed in question (B.)under Assembler Testing, attach the detailed instructions for
performing the test where the rejection limits are specified.
Details
H. For each test method listed in question (B.), please attach sample raw test data.
Details
I.

Is the actual compliance value calculated from the raw test data?

317.0 Alignment of the Center of the Radiographic X-Ray Field
Requirement:
A.

Message:

For stationary general purpose x-ray systems, the center of the x-ray field shall align
with the center of the image receptor to within 2 percent of the SID (see 1020.31(e)(1)).

Message:

For other x-ray systems, the center of the x-ray field shall align with the center of the
image receptor to within 2 percent of the SID unless means are provided to size and
align the x-ray fieldsuch that the x-ray field at the plane of the image receptor does not
extend beyond any edge of the image receptor see 1020.31(f)(2) and (4)).

Applicability:
Message:

This requirement is applicable to beam-limiting devices used in radiographic x-ray systems
other than (a) mobile x-ray systems; (b) systems for spot filming; (c) systems intended solely
for intraoral image receptors; and (d) systems used solely for mammography. Similar models
of a single component type may be grouped for presentation of test results applicable to this
requirement when thetechnical basis for this grouping is clearly stated in the description of
prototype testing (see (a) under Prototype Testing).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

Message:

To assure compliance with the centering requirement, the testresults must include data
for various combinationsof SIDS and image receptor sizes.

Describe the direct test method (i.e., one that actually measures x radiation) employed in testing and
measuring each modelwith respect to this requirement.

Identify the instrument(s) used for the test by manufacturer and model number.

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C. Attach a sample of raw test data.
Details
D. Is the actual compliance value calculated from the raw test data?
E.

Attach a sample of calculated compliance values complete with an explanation of any correction factors
employed.
Details

Explain how compliance is established.
Production Testing:
A. Does the testinvolve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.
Details

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

Please attach a sample of calculated compliance values complete with an explanation of any
correction factors employed.
Details

Explain how compliance is established.
J.

Is this performance parameter tested on 100 percent of the produced models?

Assembler Testing:
Does assembler testing apply?
A. Does the test involve a direct test of the performance parameter?
B.

Describe all methods employed in testing of each model with respect to this requirement. If reference is
made to a test protocol document, provide a copy as an attachment for documentation.

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Details
C. If any test used to monitor compliance does not actually measure x radiation, explain why it is an
accurate indication of compliance with this requirement.
D. Submit the technical data that supportsthe use of the test in question (C.)
Details
E.

Attach a copy of the detailed instructions for performing each test.
Details

Identify the instrument(s) used for each test by manufacturer and model number.
Details

Is the actual compliance value calculated from the raw test data?

318.0 Radiographic X-Ray Field Size and Image Receptor Size
Requirement:
A.

Message:

General purpose stationary x-ray systems: The beam-limiting device shall numerically
indicate the field size in the plane of the image receptor to which it is adjusted. Indication
of field size dimensions and SID's shall be specified in inches and/or centimeters and
shall be such that aperture adjustments result in x-ray field dimensions in the plane of
the image receptor that correspond to those indicated by the beam-limiting device to
within 2 percent of the SID when the beam axis is perpendicular to the plane of the
image receptor (see 1020.31(e)(1)(ii) and (iii)).

Applicability:
Message:

This requirement is applicable to beam-limiting devices and permanently mounted cassette
holders that are used in stationary general purpose systems. Similar models of a single
component type may be grouped for presentation of test results applicable to this
requirement when the technical basis for this grouping is clearly stated in the description of
prototype testing (see 318.4(a)).

Critical Parameters and "Worst Case" Conditions:
A.

Message:

The test results must include data representative of each compatible combination of
tube housing assemblies and beam-limiting devices.

Message:

As a result of inherent inaccuracies of the test method and instrumentation, rejection
limits for any test must be sufficiently restrictive to assure compliance with the standard.

C. Message:

Since the SID is used for calculating the compliance values of this requirement, the
accuracy of the SID measurement must be verified.

Prototype Testing:

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This section is for start up prior to full production phase and thus the testing and quality control procedures
may not be the same as production testing. If this does not apply go to 318.5 for production testing. Does
prototype testing apply?
A.