FDA 3661 A Guide for the Submission of an Abbreviated Report on X

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

FORM FDA 3661 (6/15)
A Guide for the Submission of an Abbreviated Report on
X-ray Tables, Cradles, Film Changers or Cassette Holders
Intended for Diagnostic Use

Public reporting burden for this collection of information is estimated to average 5 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 3661 (6/15)

A GUIDE FOR THE SUBMISSION OF AN
ABBREVIATED INITIAL REPORT ON X-RAY TABLES,
CRADLES, FILM CHANGERS OR CASSETTE
HOLDERS INTENDED FOR DIAGNOSTIC USE

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

FORM FDA 3661 (6/15)

INTRODUCTION
This guide presents an outline for a manufacturer to follow in preparing an abbreviated report, or
abbreviated supplemental report, on x-ray tables, cradles, film changers or cassette holders
intended for diagnostic use. These certifiable components are subject to the Performance
Standard, 21 CFR 1020.30, 1020.31, and 1020.32.
The focus of the guide is to identify the pertinent information required by the Food and Drug
Administration for the specified certifiable components. Information submitted will be
considered toward fulfillment of the requirements of the Radiation Control for Health and Safety
Act of 1968 (Public Law 90-601).
This reporting guide should be considered as a replacement for all previous guides that have
been developed for presentation of initial report and supplemental report data. Manufacturers
should discontinue usage of the earlier guides. This guide only applies to the above listed
components.
NOTE: All reports submitted under this abbreviated guide must be in English.

FORM FDA 3661 (6/15)

PART 100 – IDENTIFICATION
101.0

REPORT IDENTIFICATION
Confirm that this report is submitted pursuant to paragraph (c)(1) of section 1002.61,
and state the following:
Report type (initial report or supplement to CDRH Accession #

)

Identification of manufacturer
Name, address and telephone number of submitter

Email address of submitter
Identification of corresponding official

102.0

PRODUCT IDENTIFICATION

102.1

Provide the model designation as would appear on the component identification label
for all components being certified in this report. Applicable components are x-ray
tables, cradles, film changers and/or cassette holders.

102.2

If any of the models reported above are sold under names other than your own, provide
the model designation and name and address of each company under whose name the
product is sold.

102.3

For every model listed under 102.1, provide an exact replica of all labels completed
with the following items filled in as would be found on the component when shipped:
(a)
(b)
(c)
(d)
(e)

102.4

certification statement;
name and address of the manufacturer;
date and place of manufacture;
model designation and sample serial number; and
a drawing indicating the location of the labels.

Attach the following information as appendices:
(a) assembler's manual – Appendix A;
(b) user's manual (with product specifications) – Appendix B.

FORM FDA 3661 (6/15)

PART 200 – COMPONENT DESCRIPTION FOR X-RAY TABLES, CRADLES,
FILM CHANGERS OR CASSETTE HOLDERS
This section should be completed for each table, cradle, film changer or cassette holder listed in
section 102.1 of Part 100, or any combination thereof.
200.1

For each model x-ray table, identify appropriate characteristics: stationary table,
movable table, table designed for therapy simulation, table designed for computed
tomography, cantilevered table, etc.

200.2

For each model cradle, identify the means for patient restraint and rotation about the
long (longitudinal) axis. Indicate whether the model is a mobile stretcher design with
three or more hinged radiolucent panels.

200.3

For each model film changer, explain the means whereby an exposure or a series of
exposures lasting longer than one-half second is terminated.

200.4

For each vertical cassette holder equipped with size sensors, indicate the intended
image receptor sizes.

FORM FDA 3661 (6/15)

PART 300 – QUALITY CONTROL TESTING ALUMINUM EQUIVALENCE
This section requires documentation and test data assuring that the aluminum equivalence of
x-ray tables, cradles, and front panels of film changers and cassette holders, as may be used
between the patient and image receptor, does not exceed the limits indicated in Table II of the
performance standard (21 CFR 1020.30(n)).
300.1

Critical Parameters
a.

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

b. Whereas peak tube potential is critical in determining aluminum
equivalence, the test method(s) must include a procedure for the periodic
calibration of tube potential.
c.

300.2

Compliance shall be measured at 100 kVp and 2.7 millimeters of aluminum
half-value layer.

Prototype Testing
a.

Describe the direct test method that actually measures x radiation.

b. Identify all test instruments by manufacturer and model number.
c.

Describe the procedure for periodic calibration of the test instruments.

d. Provide prototype test data and rejection limits.
e.
300.3

Provide an analysis of the prototype test data.

Production Testing
a.

Describe the direct or indirect test method used to determine aluminum
equivalence.

b. Identify all test instruments by manufacturer and model number.
c.

Describe the procedure for periodic calibration of the test instruments.

d. If sampling is used for production testing, give the basis for the selected
sampling plan.
e.

Provide production test data and rejection limits.

f.

Provide an analysis of the production test data.

FORM FDA 3661 (6/15)