Fda 2579 Report Of Assembly Of A Diagnostic X-ray System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

Distribution List:
Purchaser
Assembler
State Radiation Health Office

Form Approved: OMB No. 0910-0025
Expiration Date: August 31, 2023
See Reverse for PRA statement
Assembler/Purchaser Control Number

REPORT OF ASSEMBLY
OF A DIAGNOSTIC X-RAY SYSTEM

1. EQUIPMENT LOCATION

2. ASSEMBLER INFORMATION

a. NAME OF HOSPITAL, DOCTOR OR OFFICE WHERE INSTALLED

a. COMPANY NAME

b. STREET ADDRESS

b. STREET ADDRESS

c. CITY

d. STATE

e. ZIP CODE

c. CITY

f. TELEPHONE NUMBER

d. STATE

e. ZIP CODE

f. TELEPHONE NUMBER

3. GENERAL INFORMATION
a. THIS REPORT IS FOR ASSEMBLY OF CERTIFIED COMPONENTS WHICH ARE (Check appropriate box(es))
REASSEMBLY - MIXED SYSTEM (Both certified and non-certified components)
NEW ASSEMBLY - FULLY CERTIFIED SYSTEM

REPLACEMENT COMPONENTS IN AN EXISTING SYSTEM

REASSEMBLY - FULLY CERTIFIED SYSTEM

AN ADDITION TO AN EXISTING SYSTEM

b. INTENDED USE(S) (Check appropriate box(s))
GENERAL PURPOSE RADIOGRAPHY

UROLOGY

CT WHOLE BODY SCANNER

RADIATION THERAPY SIMULATOR

GENERAL PURPOSE FLUOROSCOPY

MAMMOGRAPHY

HEAD-NECK (Medical)

C-ARM FLUOROSCOPIC

TOMOGRAPHY (Other than CT)

CHEST

DENTAL-INTRAORAL

DIGITAL

ANGIOGRAPHY

CHIROPRACTIC

DENTAL-CEPHALOMETRIC

BONE MINERAL ANALYSIS

PODIATRY

CT HEADSCANNER

DENTAL PANORAMIC

c. THE X-RAY SYSTEM IS (Check one)

OTHER
(Specify in comments)

DENTAL-CT

d. THE MASTER CONTROL IS IN ROOM

e. DATE OF ASSEMBLY

STATIONARY
MOBILE

(mm)

(dd)

(yyyy)

4. COMPONENT INFORMATION (If additional space is needed for this section use another form, replacing the preprinted number with
this Form Number, and complete Items 1, 4, and 5 only)
a. THE MASTER CONTROL IS

b. CONTROL MANUFACTURER

d. CONTROL SERIAL NUMBER

e. DATE MANUFACTURED

A NEW INSTALLATION
EXISTING (Certified)

f. SYSTEM MODEL NAME (CT Systems Only)

c. CONTROL MODEL NUMBER

EXISTING (Non-certified)

Complete the following information for the certified components listed below which you installed. For beam limiting devices, tables and CT gantries enter the manufacturer and Model number in the indicated spaces.
For other certified components, enter in the appropriate blocks how many of each you installed in this system.
g.

h.

SELECTED COMPONENTS
MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

OTHER CERTIFIED COMPONENTS
(Enter number of each installed in appropriate blocks.)

X-RAY CONTROL

CRADLE

HIGH VOLTAGE GENERATOR

FILM CHANGER

VERTICAL CASSETTE HOLDER
MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

IMAGE INTENSIFIER

TUBE HOUSING ASSEMBLY
SPOT FILM DEVICE
DENTAL TUBE HEAD

MANUFACTURER

MODEL NUMBER

MANUFACTURER

MODEL NUMBER

CEPHALOMETRIC DEVICE

FLUOROSCOPIC IMAGING
ASSEMBLY

IMAGE RECEPTOR SUPPORT DEVICE

IMAGE RECEPTOR

OTHER

FLUOROSCOPIC AIR
KERMA DISPLAY DEVICE

DATE MANUFACTURED

DATE MANUFACTURED

5. ASSEMBLER CERTIFICATION
I affirm that all certified components assembled or installed by me, for which this report is being made, were adjusted and tested by me according to the instructions provided by the manufacture(s), were of the type
required by the manufacturer(s), were of the type required by the diagnostic x-ray performance standard (21 CFR Part 1020), were not modified to adversely affect performance, and were installed in accordance with
provisions of 21 CFR Part 1020. I also affirm that all instruction manuals and other information required by 21 CFR Part 1020 for this assembly have been furnished to the purchaser and, within 15 days following
completion of the assembly, a copy of this form will be submitted to the purchaser and, where applicable, to the State agency responsible for radiation protection.
a. PRINTED NAME

b. SIGNATURE

6. COMMENTS

FORM FDA 2579 (12/22)

PREVIOUS EDITIONS MAY BE USED

Contact Information for State Radiation Health Offices is available on the website of the Conference of Radiation Control Program Directors (CRCPD), https://www.crcpd.org/mpage/Map
Form may be downloaded at: https://www.fda.gov/media/144454/download

EF

Contact Information for State Radiation Health Offices is available on the website
of the Conference of Radiation Control Program Directors (CRCPD),
https://www.crcpd.org/mpage/Map
Form may be downloaded at: https://www.fda.gov/media/144454/download
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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FORM FDA 2579 (12/22)

PREVIOUS EDITIONS MAY BE USED