FDA 3627 CT X-Ray (esubmitter)

Reporting and Recordkeeping for Electronic Products - General Requirements

3627 CT 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⚠️ Notice: This form may be outdated.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:

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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 CT Products
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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Part 100 - Identification
101.0 Definitions
As used in this guide and 21 CFR 1020.30, 1020.31, 1020.32 and 1020.33, the following
definitions apply:
(1) "Accessible surface" means the external surface of the enclosure or housing provided by the
manufacturer.
(2) "accessory component" means
a) A component used with diagnostic x-ray systems, such as a cradle or film changer, that is not
necessary for the compliance of the system with applicable provisions of this subchapter but
which requires an initial determination of compatibility with the system; or
b) A component necessary for compliance of the system with applicable provisions of this
subchapter but which may be interchanged with similar compatible components without affecting
the system's compliance, such as one of a set of interchangeable beam-limiting devices; or
c) A component compatible with all x-ray systems with which it may be used and that does not
require compatibility or installation instructions, such as a tabletop cassette holder.
(3) "Air kerma" means kerma in air (see kerma).
(4) "Air kerma rate" (AKR) means the air kerma per unit time.
(5) "Aluminum equivalent" means the thickness of aluminum (type 1100 alloy) affording the same
attenuation, under specified conditions, as the material in question.
(6) "Articulated joint" means a joint between two separate sections of a table top which joint
provides the capacity for one of the sections to pivot on the line segment along which the sections
join.
(7) "Assembler" means any person engaged in the business of assembling, replacing, or installing
one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray
system or his or her employee or agent who assembles components into an x-ray system that is
subsequently used to provide professional or commercial services.
(8) "Attenuation block" means a block or stack of type 1100 aluminum alloy or aluminum alloy
having equivalent attenuation with dimensions 20 centimeters or larger by 20 centimeters or larger
by 3.8 centimeters. When used, the attenuation block shall be large enough to intercept the entire
x-ray beam.
(9) "Automatic exposure control" (AEC) means a device which automatically controls one or more
technique factors in order to obtain at a pre-selected location(s) a required quantity of radiation.

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(10) "Automatic exposure rate control" (AERC) means a device which automatically controls one or
more technique factors in order to obtain at a preselected location(s) a required quantity of radiation
per unit time.
(11) "Beam axis" means a line from the source through the centers of the x-ray fields.
(12) "Beam-limiting device" means a device which provides a means to restrict the dimensions of
the x-ray field.
(13) "C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the
x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a
system allows a change in the direction of the beam axis with respect to the patient without moving
the patient.
(14) "Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be
extended at least 100 centimeters beyond the support.
(15) "Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the
position of an x-ray film cassette during an x-ray exposure.
(16) "Cephalometric device" means a device intended for the radiographic visualization and
measurement of the dimensions of the human head.
(17) "Coefficient of variation" means the ratio of the standard deviation to the mean value of a
population of observations.
(18) "Computed Tomography" (CT) means the production of a tomogram byte acquisition and
computer processing of x-ray transmission -.
(19) "Control panel" means that part of the x-ray control upon which remounted the switches, knobs,
pushbuttons, and other hardware necessary for manually setting the technique factors.
(20) "Cooling curve" means the graphical relationship between heat units stored and cooling time.
(21) "Cradle" means:
(a) A removable device which supports and may restrain a patient above an x-ray table; or
(b) A device; (i) Whose patient support structure is interposed between the patient and the image
receptor during normal use; (ii) Which is equipped with means for patient restraint; and (iii)
Which is capable of rotation about its long (longitudinal) axis
(22) "CT Gantry" means tube housing assemblies, beam-limiting devices, detectors, and the
supporting structures, frames, and covers which hold and/or enclose these components.
(23) "Cumulative air kerma" means the total air kerma accrued from the beginning of an
examination or procedure and includes all contributions from fluoroscopic and radiographic
irradiation.
(24) "Diagnostic source assembly" means the tube housing assembly with abeam-limiting device
attached.

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(25) "Diagnostic x-ray system" means an x-ray system designedfor irradiationof any part of the
human body for the purpose of diagnosis or visualization.
(26) "Dose" means the absorbed dose as defined by the International Commission on Radiation
Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean
energy imparted by ionizing radiation to matter of mass dm.
(27) "Equipment" means x-ray equipment."Exposure" (X) means the quotient of dQ by dm where
dQ is the absolute value of the total charge of the ions of one sign produced in air when all the
electrons (negatrons and positrons) liberated by photons in a volume element of air having mass dm
are completely stopped in air. "Exposure" is also used with a second meaning to refer to the process
or condition during which the x-ray tube produces x-ray radiation. Field emission equipment means
equipment which uses an x-ray tube in which electron emission from the cathode is due solely to
action of an electric field.
(28) "Field emission equipment" means equipment which uses an x-ray tube in which electron
emission from the cathode is due solely to the action of an electric field.
(29) "Fluoroscopic radiation-emissions-display device" means a device, subsystem or component
that provides the displays of AKR and cumulative air kerma required by 1020.32(k). It includes
radiation detectors, if any, electronic and computer components, associated software, and data
displays.
(30) "Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a set of
fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It
includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage
between the image receptor and diagnostic source assembly.
(31) "Fluoroscopy" means a technique for generating x-ray images and presenting them
continuously as visible images for the purpose of providing the user a visual display of dynamic
processes.
(32) "General purpose radiographic x-ray system" means any radiographic-ray system which, by
design, is not limited to radiographic examination of specific anatomical regions.
(33) "Half-value layer, (HVL)" means the thickness of specified material which attenuates the beam
of radiation to an extent such that the air kerma rate is reduced to one-half of its original value. In
this definition the contribution of all scattered radiation, other than any which might be present
initially in the beam concerned, is deemed to be excluded.
(34) "Image Intensifier" means a device, installed in its housing, which instantaneously converts an
x-ray pattern into a corresponding light image of higher energy density.
(35) "Image receptor" means any device, such as a fluorescent screen, radiographic film, x-ray
image intensifier tube, solid-state detector, or gaseous detector, which transforms incident x-ray
photons either into visible image or into another form which can be made into a visible image by
further transformations. In those cases where means are provided to reselect a portion of the image
receptor, the term "imagereceptor" shall mean the preselected portion of the device.

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(36) "Image receptor support device" means, for mammography x-ray systems, that part of the
system designed to support the image receptor during a mammographic examination and to provide
a primary protective barrier.
(37) "Isocenter" means the center of the smallest sphere through which the beam axis passes when
the equipment moves through a full range of rotations about a common center.
(38) "Kerma" (K) means the quantity as defined by the International Commission on Radiation Units
and Measurements. The kerma, K, is the quotient of dEtr by dm where dEtr is the sum of the initial
kinetic energies offal the charged ionizing particles liberated by uncharged ionizing particles in a
material of mass dm. When the material is air, the quantity is "air kerma."
(39) "Last image hold (LIH) radiograph" means an image obtained either by retaining one or more
fluoroscopic images, which may be temporally integrated, at the end of a fluoroscopic exposure or
by initiating a separate and distinct radiographic exposure automatically and immediately in
conjunction with termination of the fluoroscopic exposure.
(40) "Lateral fluoroscope" means the x-ray tube and image receptor combination in a biplane system
dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the
lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel
to the plane of the table.
(41) "Leakage radiation" means radiation emanating from the diagnostic source assembly except for:
(i)The useful beam and
(ii) Radiation produced when the exposure switch or timer is not activated.
(42) "Leakage technique factors" means the technique factors associated with the tube housing
assembly which are used in measuring leakage radiation. They are defined as follows:
(i)For tube housing assemblies intended for capacitor energy storage equipment, the maximumrated peak tube potential and the maximum-rated number of exposures in an hour for operation at
the maximum-rated peak tube potential with the quantity of charge per exposure being
10millicoulombs (or 10 mAs) or the minimum obtainable from the unit, whichever is larger.
(ii) For diagnostic source assemblies intended for field emission equipment rated for pulsed
operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray
pulses in an hour for operation at the maximum-rated peak tube potential; and(iii) For all other
diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated
continuous tube current for the maximum-rated peak tube potential.
(43) "Light field" means that area of the intersection of the light beam from the beam-limiting device
and one of the set of planes parallel to and including the plane of the image receptor whose
perimeter is the locus of points at which the illumination is one-fourth of the maximum in the
intersection.
(44) "Line-voltage regulation" means the difference between the no-load and the load line potentials
expressed as a percent of the load line potential; that is, Percent line-voltage regulation = 100(Vn
-Vi)/Viwhere:Vn = No-load line potential andVi = Load line potential.

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(45) "Maximum line current" means the route mean square current in the supply line of an x-ray
machine operating at its maximum rating.
(46) "Mode of operation" means, forfluoroscopic systems,a distinct method of fluoroscopy or
radiography selected with a set of technique factors or other control settings uniquely associated
with the mode. Examples of distinct modes of operation include normal fluoroscopy(analog or
digital), high-level control fluoroscopy, cineradiography(analog), digital cineradiography, digital
subtraction angiography, electronic radiography using the fluoroscopic image receptor,
andphotospot recording. In a specific mode of operation, certain system variables affecting air
kerma, air kerma rate, or image quality, such as image magnification, x-ray field size, pulse rate,
pulse duration, number of pulses per exposure series, SID, or optical aperture, may be adjustable or
may vary; their variation per se does not comprise a mode of operation different than the one that
has been selected.
(47) "Movable tabletop" means a tabletop which, when assembled for use, is capable of movement
with respect to its supporting structure within the plane of the tabletop.
(48) "Nonimage-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.
(49) "Peak tube potential" means the maximum value of the potential difference across the x-ray
tube during an exposure.
(50) "Primary protective barrier" means the material, excluding filters, placed in the useful beam to
reduce the radiation exposure for protection purposes.
(51) "Pulsed mode" means operation of the x-ray system such that the x-ray tube current is pulsed by
the x-ray control to produce one or more exposure intervals of duration less than one-half second.
(52) "Quick change x-ray tube" means an x-ray tube designed for use in its associated tube housing
such that:
(i) The tube cannot be inserted in its housing in a manner that would result in noncompliance of
the system with the requirements of paragraphs (k) and (m) of section 1020.30;
(ii) The focal spot position will not cause noncompliance with the provisions of sections 1020.30
through 1020.33;
(iii) The shielding within the tube housing cannot be displaced; and
(iv) Any removal and subsequent replacement of a beam-limiting device during reloading of the
tube in the tube housing will not result in noncompliance of the x-ray system with the applicable
field limitation and alignment requirements of 1020.31 through 1020.33.
(53) "Radiation therapy simulation system " means a radiographic or fluoroscopic x-ray system
intended for localizing the volume to be exposed during radiation therapy and confirming the
position and size of the therapeutic irradiation field
(54) "Radiography" means a technique for generating and recording an x-ray pattern for the purpose
of providing the user withanimage(s) after termination of the exposure.

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(55) "Rated line voltage" means the range of potentials, in volts, of the supply line specified by the
manufacturer at which the x-ray machine is designed to operate.
(56) "Rated output current" means the maximum allowable load current of the x-ray high-voltage
generator.
(57) "Rated output voltage" means the allowable peak potential, in volts, at the output terminals of
the x-ray high-voltage generator.
(58) "Rating" means the operating limits specified by the manufacturer.
(59) "Recording" means producing a permanent form of an image resulting from x-ray photons (e.g.,
film, videotape).
(60) "Response time" means the time required for an instrument system to reach 90 percent of its
final reading when the radiation-sensitive volume of the instrument system is exposed to a step
change in radiation flux from zero sufficient to provide a steady state midscale reading.
(61) "Scan" means the complete process of collecting x-ray transmission data for the production of a
tomogram. Data may be collected simultaneously during a single scan for the production of one or
more tomograms.
(62) "Scan time" means the period of time between the beginning and end of x-ray transmission data
accumulation for a single scan.
(63) "Solid state x-ray imaging device" means an assembly, typically in a rectangular panel
configuration, that intercepts x-ray photons and converts the photon energy into a modulated
electronic signal representative of the x-ray intensity over the area of the imaging device. The
electronic signal is then used to create an image for display and/or storage.
(64) "Source" means the focal spot of the x-ray tube.
(65) "Source-image receptor distance, (SID)" means the distance from the source to the center of the
input surface of the image receptor.
(66) "Source-skin distance (SSD)" means the distance from the source to the center of the entrant
x-ray field in the plane tangent to the patient skin surface.
(67) "Spot-film device" means a device intended to transport and/or position a radiographic image
receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to
hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a
radiograph.
(68) "Stationary equipment" means equipment which is installed in affixed location.
(69) "Stationary tabletop" means a tabletop which, when assembled for use, is incapable of
movement with respect to its supporting structure within the plane of the tabletop.
(70) "Technique factors" means the conditions of operation. They are specified as follows: I. For
capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;ii. For
field emission equipment rated for pulsed operation, peak tube potential ink V, and number of x-ray

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pulses; and iii. For CT equipment designed for pulsed operation, peak tube potential in kV, scan
time in seconds, and either tube current in mill amperes (mA), x-ray pulse width in seconds, and the
number of x-ray pulses per scan, or the product of the tube current, x-ray pulse width, and the
number of x-ray pulses in mAsiv. For CT equipment not designed for pulsed operation, peak tube
potential ink V, and either tube current in mA and scan time in seconds, or the product of tube
current and exposure time in mAs and the scan time when the scan time and exposure time are
equivalent; and v. For all other equipment, peak tube potential in kV, and either tube current in mA
and exposure time in seconds, or the product of tube current and exposure time in mAs.
(71) "Tomogram" means the depiction of the x-ray attenuation propertiesof a section through a
body.
(72) "Tube" means an x-ray tube, unless otherwise specified.
(73) "Tube housing assembly" means the tube housing with tube installed. It includes high-voltage
and/or filament transformers and other appropriate elements when they are contained within the tube
housing.
(74) "Tube ratingchart" means the set of curves which specify the rated limits of operation of the
tube in terms of the technique factors.
(75) "Useful beam" means the radiation which passes through the tube housing port and the aperture
of the beam-limiting device when the exposure switch or timer is activated.
(76) "Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for
stepless adjustment of the x-ray field size at a given SID.
(77) "Visible area" means that portion of the input surface of the image receptor over which incident
x-ray photons are producing a visible image.
(78) "X-ray control" means a device which controls input power to the x-ray high-voltage generator
and/or the x-ray tube. It includes equipment such as timers, photo timers, automatic brightness
stabilizers, and similar devices, which control the technique factors of an x-ray exposure.
(79) "X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray
equipment are as follows:(i) Mobile x-ray equipment means x-ray equipment mounted on a
permanent base with wheels and/or casters for moving while completely assembled;(ii) Portable
x-ray equipment means x-ray equipment designed to be hand-carried; and(iii)Stationary x-ray
equipment means x-ray equipment which is installed in affixed location.
(80) "X-ray field" means that area of the intersection of the useful beam and any one of the set of
planes parallel to and including the plane of the image receptor, whose perimeter is the locus of
points at which the exposure rate is one-fourth of the maximum in the intersection.
(81) "X-ray high-voltage generator" means a device which transforms electrical energy from the
potential supplied by the x-ray control to the tube operating potential. The device may also include
means for transforming alternating current to direct current, filament transformers for the x-ray tube
(s), high-voltage switches, electrical protective devices, and other appropriate elements.
(82) "X-ray system" means an assemblage of components for the controlled production of x rays. It
includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a

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beam-limiting device, and the necessary supporting structures. Additional components which
function with the system are considered integral parts of the system.
(83) "X-ray subsystem" means any combination of two or more components of an x-ray system for
which there are requirements specified in1020.30, 1020.31 and 1020.32.
(84) "X-ray table" means a patient support device with its patient support structure (tabletop)
interposed between the patient and the image receptor during radiography and/or fluoroscopy. This
includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table
equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film
device beneath the tabletop.
(85) "X-ray tube" means any electron tube which is designed for the conversion of electrical energy
into x-ray energy.
102.0 - Product Identification
Note:

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

Enter the System Designation: (If you do not use a Model Family or Brand Name, leave the field blank)
Item

Model Name

Family Name

Brand Name

Head and/or Body Scanner?

102.1 Certifiable component
103.0 - Labeling / Information
Note:

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

103.1 - Appendix A
Note:

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

Note:

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

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manufacturing date for the entire CT system.Content 21 CFR Reference1. Certification
Labels 1010.22. Identification Labels 1010.33. Warning Labels 1020.30(j)
Attach PDF file here.
Certification labels are found on PDF page numbers:
Identification labels are found on PDF page numbers:
Warning labels are found on PDF page numbers:

103.2 - Appendix B
Note:

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

Note:

Provide a copy of the assembler information requested below.

Is this data located in a PDF file?
Attach PDF file here.
Assembly & test instructions to assure compliance (21 CFR Reference:
1020.30(g)). PDF page numbers:
Compatibility specifications (21 CFR Reference: 1020.30(g)). PDF page
numbers:
Tube reloading instructions (21 CFR Reference: 1020.30(e)). PDF page
numbers:
Please provide the assembly & test instructions to assure compliance (21 CFR Reference: 1020.30(g))
Please provide the compatibility specifications (21 CFR Reference: 1020.30(g))
Please provide the tube reloading instructions (21 CFR Reference: 1020.30(e))

103.3 - Appendix C
Note:

Note:

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

Is this data located in a PDF file?

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

103.4 - Appendix D
Note:

Provide a copy of the Operator's Manual and other user information listed below. Provide
below the exact page number of the location of each item. All user information listed below

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shall be identified and provided in a separate section of the user instruction manual or in a
separate manual devoted only to this information.
Is this data located in a PDF file?
Attach PDF file here.
A statement of the CT conditions of operation used to provide the dose
information requested below and inappendix E, part 5 (21 CFR Reference:
1020.33(c)(1)). PDF page numbers:
Dose Information (21 CFR Reference: 1020.33(c)(2)) and Imaging Performance
Information (1020.33(c)(93)). PDF page numbers:
a

Note:

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

A statement of the noise. PDF page numbers:
b

Note:

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

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

Note:

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

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

Note:

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

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

Note:

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

A description of the phantom or device and test protocol or procedure
used to determine the specifications and a statement of the maximum
deviation from the specifications for items (a-d) above. PDF page
numbers:

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A statement of the CT conditions of operation used to provide the dose information requested below and in
appendix E, part 5 (21 CFR Reference: 1020.33(c)(1))
Dose Information (21 CFR Reference: 1020.33(c)(2)) and Imaging Performance Information (1020.33(c)(93))
a

Note:

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

A statement of the noise
b

Note:

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

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

Note:

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

A statement of the nominal tomographic section thickness(es)
d

Note:

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

Note:

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

A description of the phantom or device and test protocol or procedure used to determine the
specifications and a statement of the maximum deviation from the specifications for items (a-d)
above

103.5 - Appendix E

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Note:

Is this data located in a PDF file?
Attach PDF file here.
Quality assurance instructions*(21 CFR Reference: 1020.33(d))
1.

Phantom description. PDF page numbers:

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

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

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

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

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

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

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Part 200 - System Description
201.0 - Control/Indication CT Conditions of Operation - Visual Indication
Note:

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

All CT conditions of operation must be displayed prior to the initiation of each scan or scan sequence
(1020.33(f)(1)). Along witha description of the means provided, you should include a drawing or picture of the
preindicators of technique factors to the operator. Click on the Add... button below to attach any supporting
files.
Details
The displayed conditions of operation must be visible from any position from which scan initiation is possible
(1020.33(f)(1)). Provide a drawing or picture that illustrates the proximity of any exposure switch to the
preindicatedtechnique factors. Click on the Add... button below to attach any supporting files.
Details

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

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

Note:

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

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

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

203.0 - Tomographic Plane Indication & Alignment
Note:

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

Note:

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

Is this data located in a PDF file?
Attach PDF file here.
For any single tomogram, system, means shall be provided to permit visual
determination of the tomographic plane or an offset reference plane (1020.33(g)
(1)). Describe thespecific means utilized for indication of location on the patient
where the tomogram will be obtained. PDF page numbers:
For any multiple tomogram system, means must be provided to permit visual
determination of the location of a reference plane (1020.33(g)(2)). For multiple
tomogram systems, describe the relationship of the reference plane alignment to
the actual position of the tomograms. PDF page numbers:

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For any single tomogram, system, means shall be provided to permit visual determination of the tomographic
plane or an offset reference plane (1020.33(g)(1)). Describe the specific means utilized for indication of
location on the patient where the tomogram will be obtained.
For any multiple tomogram system, means must be provided to permit visual determination of the location of
a reference plane (1020.33(g)(2)). For multiple tomogram systems, describe the relationship of the reference
plane alignment to the actual position of the tomograms.

204.0 - Beam On and Shutter Status Indicators
Note:

Note:

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

Is this data located in a PDF file?
Attach PDF file here.
Means shall be provided on the x ray control and on or near the housing of the
scanning mechanism to provide visual indication when and only when X rays
are produced (1020.33(h)(1)). In addition to a description of this means, provide
a drawing or picture to show visual indicators. PDF page numbers:
If applicable, means shall be provided on the x ray control and on or near the
housing of the scanning mechanism to provide visual indication of whether the
shutter is open or closed (1020.33(h)(1)). In addition to a description of this
means, provide a drawing or picture to show the visual indicators. PDF page
numbers:
The minimum period for x ray on indication must be 0.5 seconds or greater
(1020.33(h)(1)). Describe the means provided to meet this requirement. PDF
page numbers:
Visual indicators (indicating x ray production and shutter status) on or near the
housing of the scanning mechanism shall be discernible from any point external
to the patient opening, where insertion of any part of the human body into the
primary beam is possible (1020.33(h)(1)). In addition to the description of this
means, provide a drawing or picture that illustrates the location of all indicators
at or near the housing of the scanning mechanism, in relation to the patient
opening. PDF page numbers:
Means shall be provided on the x ray control and on or near the housing of the scanning mechanism to
provide visual indication when and only when X rays are produced (1020.33(h)(1)). In addition to a description
of this means, provide a drawing or picture to show visual indicators.
If applicable, means shall be provided on the x ray control and on or near the housing of the scanning
mechanism to provide visual indication of whetherthe shutter is open or closed (1020.33(h)(1)). In addition to
a description of this means, provide adrawing or picture to show the visual indicators.

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The minimum period for x ray on indication must be 0.5 seconds or greater (1020.33(h)(1)). Describe the
means provided to meet this requirement.
Visual indicators (indicating x ray production andshutter status) on or near the housing of the scanning
mechanism shall be discernible from any point external to the patient opening, where insertion of any part of
the human body into the primary beam is possible(1020.33(h)(1)). In addition to the description of this means,
provide a drawing or picture that illustrates the location of all indicators at or near the housing of the scanning
mechanism, in relation to the patient opening.

205.0 - CT Number Mean and Standard Deviation
Note:

Note:

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

Is this data located in a PDF file?
Attach PDF file here.
Means must be provided for the user to calculate the mean and standard
deviation of CT numbers for an array of picture elements about any location in
the image (1020.33(j)(1)). Describe this means. PDF page numbers:
The number of elements in this array must be under user control (1020.33(j)(1)).
Describe the means provided to the user for varying the number of elements in
the array.PDF page numbers:
Means must be provided for the user to calculate the mean and standard deviation of CT numbers for an
array of picture elements about any location in the image (1020.33(j)(1)). Describe this means.
The number of elements in this array must be under user control (1020.33(j)(1)). Describe the means
provided to the user for varying the number of elements in the array.

206.0 - Labeling
Note:

Note:

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

Is this data located in a PDF file?
Attach PDF file here.

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

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

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

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

301.1 Requirement
Note:

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

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

301.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

301.3 Prototype Testing
Note:

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

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

301.4 Production Testing
Note:

a. Describe all methods employed in direct and indirect testing of each modelwith respect to this
requirement.b. If an indirect test is used to measure compliance, explain why it is an accurate indication of
compliance with this requirement.c. Submit the technical data that supports the use of the test in part b.d.
Provide a copy of the detailed instructions for performing each test. Attach as APPENDIX F.e. Identify the
instrument(s) used for each test by manufacturer and model number. Answer the appropriate section in Part
400 foreach instrument(s).f. For each of the above test methods give the page number of your detailed
instructions for performing the test and indicate where the rejection limits are specified.g. For each of the
above test methods, provide sample raw test data.h. If the actual compliance value is calculated from the raw
test data, provide a sample of calculated compliance values complete with an explanation of any correction
factors employed.j. A statement indicating whether the maximum CTDI is obtained from integration of the

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dose profile for a single scan or from a direct measurement of the average dose in an interval equal to the
slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

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

301.4i Sampling
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

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301.5 Assembler Testing
Note:

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

302.0 - Beam Quality
Note:

Is this data located in aPDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

302.1 Requirement
Note:

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

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

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302.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

302.3 Prototype Testing
Note:

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

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

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302.4 Production Testing
Note:

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

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

302.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test andprovide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details

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

302.5 Assembler Testing
Note:

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

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

303.0 - Peak Tube Potential
Note:

Is this data located in a PDF file?

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

303.1 Requirement
Note:

The manufacturer shall state the maximum deviation of the peak tube potential from its preindicated value
during an exposure when the equipment is connected to an adequate power supply as specified by the
manufacturer. The deviation of the pe4 tube potential shall not exceed the limits given (see 1020.30(h)(3)(vi)).
PDF page numbers:

303.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

303.3 Prototype Testing
Note:

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section in Part 400 for this instrument(s).c. Provide sample raw test data.d. If the actual compliance value is
calculated from the raw test data, provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.e. A statement indicating whether the maximum CTDI is
obtained from integration of thedose profile for a single scan or from a direct measurement of the average
dose in an interval equal to the slice thickness at the center of a series of 14 scans that are spaced by the
nominal tomographic slice thickness. PDF page numbers:

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

303.4 Production Testing
Note:

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

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

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303.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lotsize, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double samplingplan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

303.5 Assembler Testing
Note:

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test) should have already been provided in APPENDIX B and thus may bereferenced by indicating the
appropriate page numbers. PDF page numbers:

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

304.0 - Tube Current
Note:

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

304.1 Requirement
Note:

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

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

304.2 Critical Parameters and "Worst Case" Condition
Note:

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minimum, and maximum allowable line voltage regulation).b. Please note and describe any critical
parameters and "worst case" conditions which are unique to your system or test method. PDF page numbers:

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

304.3 Prototype Testing
Note:

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

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

304.4 Production Testing
Note:

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above test methods, provide sample raw test data.h. If the actual compliance value is calculated from the raw
test data, provide a sample of calculated compliance values complete with an explanation of any correction
factors employed.j. A statement indicating whether the maximum CTDI is obtained from integration of the
dose profile for a single scan or from a direct measurement of the average dose in an interval equal to the
slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

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

304.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
Theacceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)

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The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

303.5 Assembler Testing
Note:

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

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

305.0 - Scan Time
Note:

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

305.1 Requirement
Note:

The manufacturer shall state the maximum deviation of the scan time from its preindicated value during
anexposure, when the equipment is connected to an adequate power supply as specified by the

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manufacturer. The deviation of scan time shall not exceed the limits given (see 1020.30(h)(3)(vi)). PDF page
numbers:

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

305.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

305.3 Prototype Testing
Note:

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

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explanation of any correction factors employed.e. A statement indicating whether the maximum CTDI is
obtained from integration of the dose profile for a single scan or from a direct measurement of the average
dose in an interval equal to the slice thickness at the center of a series of 14 scans that are spaced by the
nominal tomographic slice thickness.

305.4 Production Testing
Note:

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

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

305.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate thePDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?

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List each performance parameter test that is sampled.
Describe the sampling plan usedfor each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

305.5 Assembler Testing
Note:

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

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

306.0 - Tube Current - Exposure Time Product

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Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

306.1 Requirement
Note:

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

306.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

306.3 Prototype Testing

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

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

306.4 Production Testing
Note:

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

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instructions for performing the test and indicate where the rejection limits are specified.g. For each of the
above test methods, provide sample raw test data.h. If the actual compliance value is calculated from the raw
test data, provide a sample of calculated compliance values complete with an explanation of any correction
factors employed.j. A statement indicating whether the maximum CTDI is obtained from integration of the
dose profile for a single scan or from a direct measurement of the average dose in an interval equal to the
slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness.

306.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameterstested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot untilsampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

306.5 Assembler Testing

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

307.0 - CTDI/Dose Profile Information
Note:

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

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

307.1 Requirement
Note:

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For each applicable test listed below, verify that the testing adequately reflects the critical
parameters and addresses the "worst case" conditions. As a resultof inherent inaccuracies of
the test methods and instrumentation, rejection limits for any test must be sufficiently
restrictive to account for these inaccuracies.
The manufacturer shall state the maximum deviation of the dose values given to the user in accordance with
sections 1020.33(c)(2)(i), (ii), (iii), and (iv). The deviation from these values shall not exceed the limits given
(1020.33(c)(2)(v)). PDF page numbers:

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

307.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

307.3 Prototype Testing
Note:

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

307.4 Production Testing
Note:

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

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

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307.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the producedmodels?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

307.5 Assembler Testing
Note:

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

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308.0 - Imaging Performance
Note:

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

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

308.1 Requirement
Note:

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

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

308.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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308.3 Prototype Testing
Note:

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

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

308.4 Production Testing
Note:

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test data, provide a sample of calculated compliance values complete with an explanation of any correction
factors employed.j. A statement indicating whether the maximum CTDI is obtained from integration of the
dose profile for a single scan or from a direct measurement of theaverage dose in an interval equal to the
slice thickness at the center of a series of 14 scans that are spaced by the nominal tomographic slice
thickness. PDF page numbers:

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

308.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size,sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerancepercent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)

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The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

308.5 Assembler Testing
Note:

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

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

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

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

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

309.1 Requirement
Note:

Means shall be provided to terminate the x ray exposure automatically by either deenergizing the x ray source
or shuttering the x ray beam in the event of equipment failure affecting data collection. Such termination shall
occur within an interval that limits the total scan time to no more than 110 percent of its preset value through

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the use of either a backup timer or devices which monitor equipment function (1020.33(f)(2)(i)). PDF page
numbers:

309.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

309.3 Prototype Testing
Note:

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

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

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dose in an interval equal to the slice thickness at the center of a series of 14 scans that are spaced by the
nominal tomographic slice thickness.

309.4 Production Testing
Note:

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

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

309.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.

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Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

309.5 Assembler Testing
Note:

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

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

310.0 - Tomographic Plane Location
Note:

Please provide the answers to each question listed by either attaching a PDF file and in
subsequent questions identify the appropriate section to review within the PDF, or by

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answering each of the listed questions directly in the text boxes provided. If attaching a PDF
file, please indicate the page or section within the PDF where the answer to each question
can be found.
Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

310.1 Requirement
Note:

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

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

310.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

310.3 Prototype Testing
Note:

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

310.4 Production Testing
Note:

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

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

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310.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leadsto a rejection decision.

310.5 Assembler Testing
Note:

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

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

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

311.1 Requirement
Note:

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

311.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

311.3 Prototype Testing

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

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

311.4 Production Testing
Note:

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

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

311.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characetristic (OC) curve (page no)
The average outgoing quality level(AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action taken if the sampling plan leads to a rejection decision.

311.5 Assembler Testing

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

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

312.0 - Shutter Leakage Radiation
Note:

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

312.1 Requirement
Note:

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

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312.2 Critical Parameters and "Worst Case" Conditions
Note:

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

312.3 Prototype Testing
Note:

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

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

312.4 Production Testing

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

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

312.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)

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

312.5 Assembler Testing
Note:

a-i. If test instructions are provided to the assembler, answerthe questions in 312.4 with respect to assembler
testing. Note: The information requested in 312.5(d) (i.e., acopy of detailed instructions for performing each
test) should have already been provided in APPENDIX B and thus may be referencedby indicating the
appropriate page numbers. PDF page numbers:

a-i. If test instructions are provided to the assembler, answer the questionsin 312.4 with respect to assembler
testing. Note: The information requested in 312.5 (d) (i.e., a copy of detailed instructions for performing each
test) should have already been provided in APPENDIX B and thus may be referenced by indicating the
appropriate page numbers.

313.0 - Scan Increment Accuracy
Note:

Is this data located in a PDF file?
Please attach any relevant documents in PDF format that provide answers and explanation for the questions
asked in this section.

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313.1 Requirement
Note:

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

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

313.2 Critical Parameters and "Worst Case" Conditions
Note:

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

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

313.3 Prototype Testing
Note:

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calculated from the raw test data, provide a sample of calculated compliance values complete with an
explanation of any correction factors employed.e. A statement indicating whether the maximum CTDI is
obtained from integration of the dose profile for a single scan or from a direct measurement of the average
dose in an interval equal to the slice thickness at the center of a seriesof 14 scans that are spaced by the
nominal tomographic slice thickness. PDF page numbers:

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

313.4 Production Testing
Note:

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

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

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313.4i Sampling
Is this sampling plan the same as any previous sampling plan?
Please Attach/Select the appropriate file
Please indicate the PDF page numbers where the sampling plan is
located:
Do you test 100% of the produced models?
Are any performance parameters tested other than 100%?
List each performance parameter test that is sampled.
Describe the sampling plan used for each performance test and provide the parameters of the plan listed
below (e.g., lot size, sample size, rejection criterion). Attach a copy of the plan.
Details
The lot size (N)
The sample size (n)
The reject level number (c)
A single or double sampling plan (S or D)
The acceptable quality level (AQL)
The lot tolerance percent defective (LTPD)
The producer's risk (alpha)
The consumer's risk (beta)
The operating characteristic (OC) curve (page no)
The average outgoing quality level (AOQL)
The procedures for segregation of the lot until sampling allows the lot to be released.
Describe the procedures used for selecting the sample and indicate how randomness is assured.
Describe the action takenif the sampling plan leads to a rejection decision.

313.5 Assembler Testing
Note:

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

file:///C:/eSubApps/eSub_Test/output/report.html

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Submission Report

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file:///C:/eSubApps/eSub_Test/output/report.html

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Submission Report

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Part 400 - Common Aspects
401.0 - Instrumentation
Note:

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

401.1 - Radiation Measurement
401.2 - Illuminance
401.3 - Electrical Measurement
401.4 - Other Measurements

file:///C:/eSubApps/eSub_Test/output/report.html

1/9/2017

File Type	application/pdf
File Title	file:///C:/eSubApps/eSub_Test/output/report.html
Author	CST
File Modified	2017-01-09
File Created	2017-01-09