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

FOR FDA USE ONLY

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
FOOD AND DRUG ADMINISTRATION

TEMPORARY

REPORT OF ASSEMBLY
OF A DIAGNOSTIC X-RAY SYSTEM

Not an official copy and Not for submittal

1. EQUIPMENT LOCATION

2. ASSEMBLER INFORMATION

HOSPITAL, DOCTOR OR OFFICE WHERE INSTALLED

COMPANY INFORMATION

3. GENERAL INFORMATION
THIS REPORT IS FOR ASSEMBLY OF CERTIFIED COMPONENTS WHICH ARE

( ) Reassembly-Mixed System (Both certified and non-certified components)
( ) Replacement Components in an Existing System
( ) An Addition to an Existing System

( ) New Assembly-Fully Certified System
( ) Reassembly-Fully Certified System
INTENDED USE(S)

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General Purpose Radiology
General Purpose Fluoroscopy
Tomography (other than CT)
Angiography
Podiatry
Other

THE X_RAY SYSTEM IS

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Urology
Mammography
Chest
Chiropractic
CT Headscanner

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CT Whole Body Scanner
Head-Neck (medical)
Dental-Intraoral
Dental-Cephalometric
Dental Panoramic

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Radiation Therapy Simulator
C-arm Fluoroscopic
Digital
Bone Mineral Analysis
Dental-CT

THE MASTER CONTROL IS IN ROOM

DATE OF ASSEMBLY

( ) Stationary ( ) Mobile

4. COMPONENT INFORMATION
THE MASTER CONTROL IS

( ) A New Installation
( ) Existing (Certified)
( ) Existing (Non-certified)

CONTROL MANUFACTURER

CONTROL SERIAL NUMBER

CONTROL MODEL NUMBER

DATE MANUFACTURED

SYSTEM MODEL NAME (CT Systems Only)

SELECTED COMPONENTS
MODEL NUMBER

DATE MFR'ED

CT
GANTRY

TABLES

BEAM
LIMITING
DEVICE

MANUFACTURER

OTHER CERTIFIED COMPONENTS (Number of each installed)

MANUFACTURER

MODEL NUMBER

MANUFACTURER

MODEL NUMBER

DATE MFR'ED

DATE MFR'ED

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] X-Ray Control
] High Voltage

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] Cradle
] Film Changer

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] Vertical Cassette

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] Image Intensifier

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] Tube Housing

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] Spot Film Device

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] Dental Tube Head

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] Fluoroscopic

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] Cephalometric

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] Image Receptor

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] Image Receptor

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] Fluorocopic Air

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] Other

Generator
Holder

Assembly

Device

Support Device

Imaging Assembly

Kerma Display
Device

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 manufacture(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 the 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, each copy of this report will be distributed as indicated at the bottom of each copy.
PRINTED NAME

SIGNATURE

DATE

6. COMMENTS

FORM FDA 2579 (05/07)
(Previous Editions May Be Used)

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