FDA 2579 Report of Assembly of a Diagnostic X-Ray System

Form should NOT be submitted
to FDA. See below for distribution
list:

Form Approved: OMB No. 0910-0025
Expiration Date: July 31, 2020
See Reverse for OMB statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

Distribution List:

Assembler/Purchaser Control Number

REPORT OF ASSEMBLY
OF A DIAGNOSTIC X-RAY SYSTEM

State Radiation Health Office
Purchaser
Assembler

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

c. CITY

d. STATE

f. TELEPHONE NUMBER

e. ZIP CODE

(

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(es))
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

CT HEADSCANNER

DENTAL PANORAMIC

OTHER (Specify in comments)

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

e. DATE OF ASSEMBLY

d. THE MASTER CONTROL IS IN ROOM

STATIONARY
MOBILE

4. COMPONENT INFORMATION
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.
SELECTED COMPONENTS

CT

GANTRY

TABLES

BEAM
LIMITING
DEVICE

g.

h.

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

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

X-RAY CONTROL

CRADLE

HIGH VOLTAGE GENERATOR

FILM CHANGER

VERTICAL CASSETTE HOLDER

IMAGE INTENSIFIER

TUBE HOUSING ASSEMBLY

SPOT FILM DEVICE

DENTAL TUBE HEAD

OTHER (Specify)

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
from the date of assembly, a copy of this form will be distributed to the state radiation health office and the facility of installation. A copy of this form will be maintained on file for five years from the date of installation.
a. PRINTED NAME

b. SIGNATURE

c. DATE

6. COMMENTS

FORM FDA 2579 (5/07)

PREVIOUS EDITIONS MAY BE USED
Form may be downloaded at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/RadiologicalHealthForms/default.htm

EF