FDA 3639 Guidance for the Submission of Cabinet X-Ray System Repo

Form Approved: OMB No. 0910-0025
Expiration Date: January 31, 2017

FORM FDA 3639 (3/14)
Guidance for the Submission of Cabinet X-Ray System
Reports Pursuant to 21 CFR 1020.40

Public reporting burden for this collection of information is estimated to average 24 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper Reduction Act (PRA) Staff
[email protected]
*Please do NOT send your completed document to this PRA Staff email address.*
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.

This guidance was written prior to the February 27, 1997 implementation of FDA’s
Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elements of GGP’s.

More industry guidance and assistance can be found at the FDA homepage, see:
http://www.fda.gov/Radiation-EmittingProducts/.

Send your completed report to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
Questions about reporting and suggestions for changes to this guide may be sent to the above
address or may be discussed by calling 1-800-638-2041.

FORM FDA 3639 (3/14)

GUIDANCE FOR THE SUBMISSION OF
CABINET X-RAY SYSTEM REPORTS PURSUANT
TO 21 CFR 1020.40

Compiled by:
Division of Compliance
X-Ray Products Branch

FEBRUARY 1975

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993

FORM FDA 3639 (3/14)

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FORM FDA 3639 (3/14)

Foreword
The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide. This guide will
assist manufacturers¹ of electronic products which emit radiation in providing adequate reporting of radiation safety testing
and compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and
1003 specify Reporting and Notification requirements²,³.
Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7). If the
report does not follow an applicable guide it must contain a sufficient justification for any deviations. The submitter of
the report will receive an acknowledgment letter with the accession number we assign to the report. Please reference this
accession number in the future when providing additional information about this model family in either a supplement or the
annual report. If a report is incomplete or inadequate CDRH may reject it and return it for completion. CDRH will not
enter a rejected report into our database. Also, a rejected report will not receive an accession number.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is the manufacturer’s
responsibility to certify that their products comply with all applicable standards (21 CFR 1010 - 1050), based on a testing
program in accordance with good manufacturing practices. Prior to the shipment of products in interstate commerce
21 CFR 1002 requires the manufacturer to submit the report and to comply with all applicable importation requirements
(21 CFR 1005). If there are deficiencies, we may disapprove the firm’s quality control and testing program, determine
that the product contains a radiation defect, or determine that the product fails to comply with a standard. We will notify
the manufacturer if we make such a determination. CDRH may require the manufacturer to cease introduction into U.S.
commerce until deficiencies are corrected, and to initiate a corrective action program (21 CFR 1003 - 1004) for products
already introduced into commerce.
Please mail your reports to the address below (FDA can not process electronic submissions at this time). Provide the
original report with appropriate signature(s) (no facsimiles, please). Provide extra copies only if this guide specifically
requires them. Submit the report written in the English language. Translate any text that appears in a language other than
English into English in a complete and accurate manner. Keep a copy of the completed reports in your records.
We are making our reporting guides and other regulatory information available on the Internet under
http://www.fda.gov/Radiation-EmittingProducts/. No copyright exists for these guides. Reproduce these guides as needed.
If you would like to comment on the reporting guides, web site, or future electronic submissions, you may direct the comments
to the address below. If you need additional regulations for electronic products or medical devices, you should contact the
Division of Small Manufacturers, International and Consumer Assistance by telephone at 1-800-638-2041 or by facsimile at
301-847-8149.
Sincerely yours,

Lillian J. Gill
Director
Office of Compliance
E-MAIL ADDRESS: [email protected]
MAILING ADDRESS (see 21 CFR 1002.7 for further information):
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
¹

Manufacturer (see 21) CFR § 1000.3(n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products.

²

Accidental Radiation Occurrences: 21 CFR 1002.20 requires manufacturers to immediately report accidental radiation occurrences (see 21 CFR
1000.3(a) for the definition).

³

Notification: Title 21 CFR Part 1003 requires manufacturers to provide Notification of Defects or Failure to Comply. Send these notifications to the
above address.

FORM FDA 3639 (3/14)

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FORM FDA 3639 (3/14)

FOREWORD

This document is intended to serve as a guide to assist manufacturers in
the submission of initial and supplements to initial reports for cabinet x-ray
systems (21 CFR 1020.40). The format selected for this guidance is that of
report form. It may be used directly or it may serve as a model for developing
a reporting form. However, if a manufacturer develops his own report form he
must be sure that all information requested by the "model" form is included and
keyed to this format since this information has been interpreted by the Division
of Compliance as being necessary to satisfy, in whole or in part, the initial
and supplemental reporting requirements. In order to standardize reports and facilitate
their review the order and organization of the model form should be followed as
closely as possible.

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FORM FDA 3639 (3/14)

CONTENTS
Page
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

i

GENERAL INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iii

CABINET X-RAY SYSTEM REPORTING FORM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

Part I - Manufacturer and Report Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

Part II - Product Identification and Technical Information . . . . . . . . . . . . . . . . . . . . .

2

A - Model Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

B - Technical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

Part III - Basic Sampling and Testing Information . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

ATTACHMENT LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

APPENDIX A - DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23

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FORM FDA 3639 (3/14)

GENERAL INSTRUCTIONS

The attached model form is to be used when submitting initial reports and
supplements to initial reports. Definitions of these types of reports and of
several other items necessary to properly complete the form are given in Appendix
A. Part I of the form covers manufacturer and report identification, Part II
covers product identification and technical information, and Part III covers
the basic sampling and testing program. The form contains specific instructions for the
completion of each part. General instructions for the preparation and submission of the
various types of reports are given below.
1.

One copy of Part I of the form is to accompany each report submission.

2.
Initial Reports - Information being submitted to meet the requirements of
an initial report will require completion of all parts of the form. A copy of Part
II (A), Part II (B) and Part III is to be completed for each model cabinet x-ray
system.
3.
Supplemental Reports - Any changes in information previously submitted
in Part II (A), Part II (B) or Part III of this form is to be submitted as
a supplement to an initial report. Only the portions of each part
undergoing change need be submitted. The date and accession number of the initial
report to which the supplement applies is to be listed in item 3 of
Part I.
4.
Attachments - Throughout the guide reference is made to attachments.
These attachments should be clearly marked according to the alphabetical
letter indicated in the guide. All attachments should be placed in order
at the end of the guide and the accompanying attachment list filled in.
The manufacturers may reference their own data identification numbers on
this list.
5.

All reports are to be submitted to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER - WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002

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FORM FDA 3639 (3/14)

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FORM FDA 3639 (3/14)

Center for Devices and Radiological Health
Document Mail Center - WO66-G609
Electronic Product Reports
10903 New Hampshire Avenue
Silver Spring, MD 20933-0002

Cabinet X-ray System Reporting Form
Part I - Manufacturer and Report Identification
This part of the form is to accompany each submission. Only one copy of this part need
be completed even though more than one copy of other parts of this form may be required
to provide all the information being reported.
1.

Manufacturer:
Name
Address
Corresponding Official: (May not be applicable for imports)
Signature
Name
Title
Email

Telephone
2.

Importer: (Complete if applicable)
Name
Address
Corresponding Official:
Signature
Name
Title
Telephone

3.

Email

Report Type:
Initial
Supplement to initial report, CDRH
Accession No.
submitted on
(dates)

4.

Report Date:

1
FORM FDA 3639 (3/14)

Part II - Product Identification and Technical Information
Complete Sections A and B for each new cabinet x-ray system being reported. A copy of
Section A and B is to be completed for each new cabinet x-ray system being reported.
Only Section A need be completed to report additional brand and/or selling model
numbers of a system when all other manufacturing and testing information is the same as
previously submitted. Any information covered in Part II (B) and/or Part III of the form
that has not been previously reported should be provided in the applicable portions of
Part II (B) and/or Part III.
A.

Model Identification
1.0 Product Type:
Reported pursuant to paragraph c of 1002.61
- check as applicable Product Type
Radiographic, conventional source
Radiographic, pulsed or flash source
Fluoroscopic
Radiographic and fluoroscopic
Screening device used in public facilities
(such as baggage inspection devices)
Other than specified types (describe below)
Description of other product types:

2.0 List the name and model number of the product manufactured or
imported to which the cabinet x-ray standard is applicable. Do not
report if the item is intended solely for export to countries whose
applicable requirements are met.
Name of Product
Model Number
3.0 If the reported model is sold under brand names, other than those
of the manufacturer, please provide the brand name, model number,
and name and address of each company under whose name the model
is sold.
Brand Name
Model Number

2
FORM FDA 3639 (3/14)

Company
Address

4.0

List all uses or applications for which the model is intended.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

5.0 Reference Verification (check one)
5.1 All information previously reported in CDRH Accession
on
(date) is applicable to the
No.
models listed under item 2, Part II (A) of this report. The models
will be manufactured and tested in accordance with the procedures
reported in the reference document.
5.2 Except as specifically indicated in Section B of Part II
and/or Part III, all information previously reported in CDRH
Accession No.
on
(date) is
applicable to the models listed under item 2, Part II (A) of this
report. These models will be manufactured and tested in
accordance with the procedures reported in the referenced
document(s).

5.3 This is the initial submission of information required
for cabinet x-ray system(s).
B.

Technical Information
1.0 X-ray Emission
1.1 Is the system designed to limit x-ray emission from the
cabinet x-ray system to an exposure of 0.5 milliroentgen in any
one hour at a point of five centimeters outside the external
surface?
No
Yes

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FORM FDA 3639 (3/14)

1.2 List the following characteristics of the x-ray system:
range of kVp adjustment
range of mA adjustment
duty cycle (see definition)
range of timer adjustment
total filtration
beam divergence
beam orientation
1.3 Describe the type, thickness, and location of shielding
incorporated into the product to limit x-ray emission at the
external surface. Provide illustrative drawings as attachment A.

1.4 Describe all service adjustments and procedures that affect
radiation leakage.

1.5 Are any doors included as part of the cabinet x-ray
system?
Yes

No

If no, proceed to section 1.6. If yes, complete the following.
1.5.1 Describe the intended purpose of each door.
Describe:

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FORM FDA 3639 (3/14)

1.6 Are any access panels included as part of the cabinet x-ray
system?
Yes

No

If no, proceed to section 2.0. If yes, complete the following.
1.6.1 Describe the intended purpose of each access
panel.
Describe:

2.0 X-ray Controls and Indicators (Provide a circuit diagram as
attachment B).
2.1 Describe the control device(s) for initiating and
terminating x-ray generation and the physical location(s).
Include the method by which x-ray exposure interruption is
accomplished (e.g., release of exposure switch, termination
of preset time, etc.) and the method of resuming operation
following x-ray generation interruption by the control
device(s).
Describe:

2.2 Describe the characteristics, operation, and location of the
main power control.

5
FORM FDA 3639 (3/14)

2.3 Describe the characteristics, operation, and location of the
key activated control. Include a statement of the key capture
condition.

2.4 Can an x-ray exposure greater than a period of one-half
second be made with this cabinet x-ray system?
Yes

No

2.4.1 If yes, are means provided to enable the operator to
terminate the exposure prior to completion of the preset
exposure period?
Yes
No
2.4.2 If no, are means provided to prevent an additional
x-ray exposure to be made? Yes
No
2.5 Describe all devices that indicate when and only when
x-rays are being generated and that can be viewed from any
location where x-ray generation can be initiated. Include
dimensions, location, and labeling.
Describe:

2.6 How long are indicators actuated when the x-ray generation
period is less than one-half second?
2.7 Does failure of any single component of the cabinet x-ray
system cause failure of more than one x-ray production
indicator?
Yes

No

2.8 Describe all other means which indicate when x-rays
are being generated that can be viewed from any door,
access panel, and port. Include dimensions, location, and
labeling.
Describe:

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FORM FDA 3639 (3/14)

2.9 Is the cabinet x-ray system designed to admit humans?
Yes

No

If no, proceed to section 3.0. If yes, complete the following.
2.9.1 Describe all exposure controls within the cabinet and
include them in the diagram provided as attachment B.
Describe:

2.9.2 Is a method provided to reset, override, or bypass the
controls described in 2.9.1 from outside the cabinet?
Yes

No

2.9.3 Describe the audible and visible warning signals
provided in the cabinet.
Describe:

2.9.4 How long are the warning signals activated prior to
the first initiation of x-ray generation after closing any door
or access panel designed to admit humans?
.
2.9.5 If any single component of the cabinet x-ray system
fails, can x-rays be produced without either the audible or
visible warning systems indicating x-ray production?
Yes

No
7

FORM FDA 3639 (3/14)

2.9.6 Does a visible signal within the cabinet remain
activated for the entire period of x-ray generation?
Yes

No

2.9.7 Provide copies (or replicas) of all signs that are
illuminated within the cabinet which explain the
meanings of the warning devices. Indicate the sign
location with pictures and/or drawings. Label these as
attachment C.
3.0 Safety Interlocks.
3.1 Describe the interlock system and provide circuit
diagrams showing interlocks and safety systems for each
door and each access panel.
The circuit diagrams may be included in attachment B or
provided separately as attachment D. Include the electrical
and mechanical characteristics of each interlock device in
the description.
Description:

3.2 Describe any provisions for adjustment of the interlocks.

3.3 Indicate the amount of door or access panel movement that is
possible prior to actuation of the interlock.

3.4 Is any part of the circuit physically removed from the
energy supply circuit to the high-voltage generator when a door
is opened.
Yes

No

3.5 Is such disconnect dependent upon any moving part other
Yes
No
than the door.
Provide drawings, sketches or engineering drawings to clearly
illustrate operation as attachment E.
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FORM FDA 3639 (3/14)

3.6 Describe how x-ray production can be resumed after any
safety interlock has been activated.
Describe:

3.7 Are the required interlock circuits designed to ensure that
the failure of one component does not result in the failure of
more than one required safety interlock?
Yes

No

3.8 Provide a circuit analysis describing the effects of critical
component failure on the interlock system. Label the analysis
Attachment F.
4.0 Warning, Certification, and Identification Labels.
4.1 Provide an exact replica of all labels which show any of
the following.
(a)
(b)
(c)
(d)

The certification statement,
the name and address of the manufacturer (or individual or
company under whose name it is sold),
the date and place of manufacturer (these should be spelled
out in full), and
the model number and serial number.

Label the replicas as attachment G.
4.1.1 Is this labeling permanently affixed to or inscribed on
the system and legible and accessible to view when the
system is fully assembled for use?
Yes

No

4.2 Is a warning label affixed at the location of any control
which can be used to initiate x-ray generation?
Yes

No

4.2.1 Is this warning label permanently affixed to or
inscribed at the location of the control, legible and
accessible to view?
Yes

No

4.2.2 Provide a copy of the warning label affixed at the
control(s) and label it attachment H.
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FORM FDA 3639 (3/14)

4.3 Describe all other warning labels and their locations and
include copies of the labels as attachment I.
Describe:

5.0 Ports and Apertures
5.1 What are the shapes and dimensions of all entrance and exit
ports?
Shape

Dimensions

1.
2.
3.
4.
5.
6.
5.2 What is the shortest distance from the primary beam to
any location in the plane or perimeter of any entrance or exit
port? (Numbers indicate same ports as in 5.1)
Distance
1.
2.
3.
4.
5.
6.

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FORM FDA 3639 (3/14)

5.3 Describe all means specifically provided as part of the
cabinet x-ray system to prevent insertion of any part of the body
through a port into primary beam.
Describe:

5.4 What are the shapes and dimensions of all apertures?
Shape

Dimensions

1.
2.
3.
4.
5.
6.
5.5 What is the purpose of each of these apertures?
(Numbers indicate same apertures as in 5.4)
1.

2.

3.

4.

11
FORM FDA 3639 (3/14)

5.

6.

5.6 Describe the means provided to prevent the insertion of any part
of the human body through these apertures. (Numbers indicate the
same apertures as in 5.4)
Means:
1.

2.

3.

4.

5.

6.

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FORM FDA 3639 (3/14)

6.0 Floors of the Cabinet X-ray Systems.
6.1 Does the design of the cabinet x-ray system depend upon
the purchaser providing a support surface that becomes the
floor of the system when installed?
Yes

No

6.2 If the answer to 6.1 is yes, describe these installation
requirements.
Describe:

6.3 Does the installation described in 6.2 constitute a
permanent installation?
Yes

No

7.0 Ground Fault.
7.1 Can a ground fault result in generation of x-rays?
Yes

No

7.2 Provide a ground fault analysis as attachment J.
8.0 Include a copy of the information packet on safety, installation, and
maintenance procedures, which is supplied to users as required by 1020.40
(c) (9) of the standard for each model, as attachment K.
9.0 Provide copies of any additional operating instructions, published
product technical data sheets, specifications sheets, applications notes, or
other published material relating to product specifications, applications,
radiation emission or radiation safety, as attachment L. A picture or
drawing of each product should also be included. Promotional sales
literature may be included, if appropriate.
10.0 Systems designed primarily for screening of hand-carried items in
public facilities.

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FORM FDA 3639 (3/14)

10.1 Describe means provided to require operator presence at
the control area during generation of x-radiation.
Describe:

10.2 Do the means described in 10.1 permit surveillance of all
ports and doors?
Yes

No

10.2.1 If no, explain

10.3 Do the means described in 10.1 permit the operator to
terminate x-ray generation at any time?
Yes

No

10.3.1 If no, explain

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FORM FDA 3639 (3/14)

Part III - Basic Sampling and Testing Information
A.

Direct Testing
1.0 Briefly explain the concept of each direct x-ray measurement test that is
done to verify compliance with the emission limit of the standard. Include in this
explanation a copy of the test method(s). Label the explanation and test methods
as attachment M.
The test described shall include, but not be limited to:
a.

Testing to evaluate effects of scattering object and placement,

b. Testing to evaluate x-ray emission prior to interruption of x-ray
generation through operation of any required safety interlock,
c. Testing to evaluate the effects on shielding from shipping,
transporting or moving the cabinet system,
d. Testing to evaluate line voltage fluctuations and critical component
deterioration,
e. Testing to evaluate effects of service adjustments and procedures,
and
f.

Final acceptance testing.

2.0 At what stage(s) (i.e., engineering prototype, initial production lot
run, production run installation, etc.) in the design, production, or
installation of the cabinet x-ray system is a direct test made to verify
compliance with the standard?
Test

Stage

1.
2.
3.
4.
5.
6.
7.
8.

15
FORM FDA 3639 (3/14)

3.0 State the limit(s) at which the unit would be rejected for each
final acceptance test.
Limit:

4.0 Describe the procedure used to determine the location(s) of
maximum radiation intensity.
Describe:

5.0 If the direct test utilizes a radiation measurement instrument
that scans the cabinet x-ray system, what is the rate of scan
(in cm/sec)?
Rate:
6.0 State the tube potential, current, beam orientation, duty cycle, and scatter
conditions that will produce the maximum external surface x-ray exposure.
tube potential
current
beam orientation

duty cycle
scatter object
scatter object position
7.0 State the distance (in centimeters) between the external surface and
.
the radiation measurement instrument

16
FORM FDA 3639 (3/14)

8.0 In each stage, described in 2.0, list the percentage or number of
items tested.
Stage

Percentage or Number

1.
2.
3.
4.
5.
6.
7.
8.
9.
B.

Radiation Instrumentation Used for Testing
1.0

Instruments used for radiation measurement.
Instruments
#1

#2

Manufacturer
Model Number
Type of Instrument
Precision of Instrument
Accuracy of Instrument
Response Time
Energy Dependence
Angular Response
Exposure Rate Dependence
Range
Effective Measurement Area

17
FORM FDA 3639 (3/14)

#3

2.0

Calibration of Instruments
2.1 Interval of time between calibration
2.2 Method of calibration, including accuracy and source
of calibration

2.3 Verification procedure used to assure proper day-to-day
operation of instrumentation

C.

Indirect Testing
1.0 If the test method used to monitor compliance with the emission
limit performance requirement is other than the direct measurement
described above, describe the method and attach a copy of the test
procedure labeled as attachment N. In addition, provide the basis for the
indirect method (any method other than a radiation exposure
measurement); explain why it is an accurate indication of compliance
with the emission requirements, and submit the technical data which
supports this conclusion.
2.0

Specify the primary purpose of each indirect test.
Test

Purpose

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

18
FORM FDA 3639 (3/14)

3.0 Specify the stage(s) in the design, production, or installation of
the system that the indirect test is made.
Test

Stage

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
4.0 For any test whose purpose is acceptance or rejection of the
system, specify the rejection limit of the product.
Test

Rejection Limit

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
5.0

Specify who has the responsibility for conducting these tests.

Specify:

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FORM FDA 3639 (3/14)

6.0 For each test conducted for the purpose of acceptance, specify the actual
number of units tested and the proportion of production output which that number
represents.
Test

D.

# Tested

Proportion of Production

Sampling
For each production line test performed for the purpose of determining product
acceptability on less than 100 percent of the output, as attachment O, answer the
following:
1.
Specify the sampling plan used and provide the parameters of the plan (i.e.,
lot size, sample size, acceptance criteria, etc.). If the sampling plan is obtained
from a set of standard sampling tables, indicate the source and type
of plan. If the sampling plan was designed specifically for this application,
indicate the requirements which were established for the plan and the
assumptions used, and whether acceptance criteria is based upon attributes or
variables.
2.
Describe the procedure used for selecting the sample and indicate how
randomness is assured.
3.
For each test or inspection specify the quality characteristics and the
specification limit(s) by which acceptable quality is distinguished from
unacceptable.
4.

Provide the operating characteristic (O.C.) curve of the sampling plan.

5.
Specify the distribution assumed and the procedures used for computing
acceptance probabilities for the O.C. curve of the sampling plan.
6.
Specify the producer's and consumer's risk of the sampling plan and indicate
at what quality level each applies.
7.
Describe the action taken if the sampling plan leads to a rejection
decision.
E.

Critical Component Testing
As attachment P, answer the following:
1.

Describe all applicable quality control and testing procedures for critical
components conducted prior to installation of the components into your
product which you consider a necessary and vital part of your testing
program to assure compliance with the Federal Performance Standard. This
shall include, but not be limited to, incoming inspection and/or subassembly testing of such items as x-ray sources, pressure pads, interlock
switches, relays and shielding components. Where applicable, the
description shall include:
a.

Vendor qualification requirements.

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FORM FDA 3639 (3/14)

b.
Incoming inspection procedures, accept/reject criteria, and
lot and sample size if not 100 percent tested. If 100 percent
tested, so state.
c.
2.

Corrective action following unit or lot rejection.

Describe all applicable life testing procedures on the x-ray system or on
those critical components incorporated into the x-ray system which you
consider a necessary and vital part of your testing program to assure
compliance with the Federal Performance Standard for the life of the
product. This description shall include, but not be limited to, the following
information:
a.
The state(s) in the development or production of a specific
model or design when life testing is conducted on the system or
critical component.
b.
A copy of the life testing protocol, including the test
method used. If previously addressed, reference may be made to
your response to other appropriate sections of your report.
c.
The period of time (e.g., years) relative to use of the unit at
an installed site which the life testing represents.

F.

Test Results: As appendix Q, provide:
1.0

The results of Quality Control testing to date as follows:
1.1 The numerical results of the direct radiation tests upon which you base
your certification, including: a) date of the test, b) state of
development, production or installation at which the test was made.
1.2 A summary of the numerical results of direct and/or indirect quality
control tests of production line units.
1.3 Where sufficient data are available, the mean, range, and standard
deviation of each type of measurement. If these values are
unavailable, other representative statistics or expressions or results may
be reported.

2.0

Summary results of tests performed to determine "worst case"
conditions for x-ray emission at the external surface of the cabinet x-ray
system.

3.0

Summary of results of critical component testing.

4.0

Summary of results of critical component or system life testing.

5.0

Describe changes in critical components occurring with time that affect
the performance of the unit with respect to applicable performance
requirements.

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FORM FDA 3639 (3/14)

ATTACHMENT LIST
(check all that are attached including any added to provide information not specifically
identified below)
Manufacturer's Own Data
Identification Number
A.

Shielding Drawings

B.

Circuit Diagrams

C.

Signs Within the Cabinet

D.

Interlock System-Circuit Diagram

E.

Drawings of Disconnect Interlock

F.

Analysis of Interlock System
Component Failure

G.

Certification and Identification
Labels

H.

Control Warning Labels

I.

Other Warning Labels

J.

Ground Fault Analysis

K.

User Information

L.

Other Information and Data

M.

Direct Test Methods

N.

Indirect Testing

O.

Sampling

P.

Critical Component Testing

Q.

Test Results

Note: This sheet, completed as applicable, is to accompany each report.

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FORM FDA 3639 (3/14)

Appendix A - Definitions
The definitions of report types and several other terms given below are provided for use
with the general guidance to assure proper completion of the attached model form and
satisfaction of reporting requirements.
1.
Initial Report - The first report from a manufacturer to CDRH on a particular
model of product. It must provide complete information on the manufacturing and testing
program that a manufacturer is employing.
2.
Supplemental Report - A report that provides details of any additions, deletions,
corrections, or changes to information previously submitted in an initial report. Reports
of this type are to be designated as supplements to the report (referenced by CDRH
Accession Number and submission data) where the information being changed was
previously submitted.
3.
"Access panel" means any barrier or panel which is designed to be removed or
opened for maintenance or service purposes, requires tools to open, and permits access to
the interior of the cabinet.
4.
"Aperture" means any opening in the outside surface of the cabinet, other than a
port, which remains open during generation of x radiation.
5.
"Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an
enclosure (hereinafter termed "cabinet") which, independently of existing architectural
structures except the floor on which it may be placed, is intended to contain at least that
portion of a material being irradiated; provide radiation attenuation, and exclude
personnel from its interior during generation of x radiation. It would include all x-ray
systems designed primarily for the inspection of carry-on baggage at airline, railroad, and
bus terminals, and in similar facilities. An x-ray tube used within a shielded part of a
building, or x-ray equipment which may temporarily or occasionally incorporate portable
shielding is not considered a cabinet x-ray system.
6.
"Door" means any barrier which is designed to be movable or opened for
routine operation purposes, does not generally require tools to open, and
permits access to the interior of the cabinet. For the purposes of paragraph (c) (4) (i)
of this section, inflexible hardware rigidly affixed to the door shall be considered part
of the door.
7.
"Duty cycle" means the amount of time x-rays can be generated or the number of
x-ray pulses that can be generated in any hour, the limit of which is determined by the
design of the x-ray system.
8.
"Exposure" 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.
9.
"External surface" means the outside surface of the cabinet x-ray system,
including the high voltage generator, doors, access panels, latches, controls knobs,
and other permanently mounted hardware and including the plane across any aperture or
port.
10.

"Floor" means the underside external surface of the cabinet.

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FORM FDA 3639 (3/14)

11.
"Ground fault" means an accidental electrical grounding of an electrical
conductor.
12.
"Port" means any opening in the outside surface of the cabinet which is
designed to remain open, during generation of x-rays, for the purpose of
conveying material to be irradiated into and out of the cabinet, or for partial insertion
for irradiation of an object whose dimensions do not permit complete insertion into the
cabinet.
13.
"Primary beam" means the x radiation emitted directly from the target and passing
through the window of the x-ray tube.
14.
"Safety interlock" means a device which is intended to prevent the generation
of x radiation when access by any part of the human body to the interior of the cabinet
x-ray system through a door or access panel is possible.
15.
"X-ray system" means an assemblage of components for the controlled generation
of x-rays.
16.
"X-ray tube" means any electron tube which is designed for the conversion of
electrical energy into x-ray energy.

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FORM FDA 3639 (3/14)