Fda 2579 Form PDF Details

The FDA 2579 form, officially known as the "Report of Assembly of a Diagnostic X-Ray System," plays a crucial role in ensuring the safety and compliance of diagnostic x-ray equipment throughout the United States. Mandated by the Department of Health and Human Services and the Food and Drug Administration, this form is a necessary component of the regulatory framework that oversees the assembly, installation, and proper functioning of x-ray systems. Its comprehensive nature requires detailed information, including the location where the equipment is installed, assembler's details, general information on the system's intended use, component specifics, and certification by the assembler that all parts meet the diagnostic x-ray performance standards as set out in 21 CFR Part 1020. The form also documents the types of systems assembled, whether they are fully certified systems, reassemblies, replacements, or additions, and covers a broad spectrum of medical applications from general radiology to more specialized fields such as mammography and dental cephalometry. An assembler's affirmation signifies that all components were adjusted, tested, not modified adversely, and installed according to federal standards, ensuring that each x-ray system assembled contributes to safe and effective medical diagnostics. This rigorous documentation process, underscored by the FDA 2579 form, epitomizes the extensive measures taken to protect public health by ensuring diagnostic x-ray equipment adheres to the highest safety standards.

QuestionAnswer
Form NameFda 2579 Form
Form Length1 pages
Fillable?No
Fillable fields0
Avg. time to fill out15 sec
Other namesform fda 2579, 2579, fda form 2579, fda 2579 form pdf printable

Form Preview Example

FOR FDA USE ONLY

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

FOOD AND DRUG ADMINISTRATION

REPORT OF ASSEMBLY

OF A DIAGNOSTIC X-RAY SYSTEM

Form Approved: OMB No. 0910-0025.

Expiration Date: November 30, 2003

TEMPORARY

1. EQUIPMENT LOCATION

HOSPITAL, DOCTOR OR OFFICE WHERE INSTALLED

ABC Company

1111 First Street

Building 10

Rockville, 21704, US

Telephone:(111) 1111-1111

2. ASSEMBLER INFORMATION

COMPANY INFORMATION

DEF Company

2222 First Street

Building 20

Rockville, Province 9999999999, AR

Telephone:111 222 3333333333

3. GENERAL INFORMATION

THIS REPORT IS FOR ASSEMBLY OF CERTIFIED COMPONENTS WHICH ARE

 

 

( ) 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

INTENDED USE(S)

 

 

 

[X] General Purpose Radiology

[X] Urology

[X] CT Whole Body Scanner

[X] Radiation Therapy Simulator

[X] General Purpose Fluoroscopy

[X] Mammography

[X] Head-Neck (medical)

[X] C-arm Fluoroscopic

[X] Tomography (other than CT)

[X] Chest

[X] Dental-Intraoral

[X] Digital

[X] Angiography

[X] Chiropractic

[X] Dental-Cephalometric

[X] Bone Mineral Analysis

[X] Podiatry

[X] CT Headscanner

[X] Dental Panoramic

[X] Dental-CT

[X] Other: Other Intended use.

THE X_RAY SYSTEM IS

THE MASTER CONTROL IS IN ROOM

DATE OF ASSEMBLY

(•) Stationary ( ) Mobile

Room A

06/30/2008

 

 

 

4. COMPONENT INFORMATION

THE MASTER CONTROL IS

CONTROL MANUFACTURER

CONTROL SERIAL NUMBER

DATE MANUFACTURED

(•) A New Installation

CM

CSN

 

 

 

 

06/2007

 

 

( ) Existing (Certified)

 

 

 

 

 

 

 

 

 

CONTROL MODEL NUMBER

 

 

SYSTEM MODEL NAME (CT Systems Only)

 

 

( ) Existing (Non-certified)

 

 

 

 

CMN

 

 

CT SMN

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SELECTED COMPONENTS

 

 

 

OTHER CERTIFIED COMPONENTS (Number of each installed)

 

 

 

 

 

 

 

 

 

 

 

 

 

MANUFACTURER

 

MODEL NUMBER

DATE MFR'ED

[ 1]

X-Ray Control

[ 6]

Cradle

 

 

 

 

 

 

 

BEAM LIMITING

 

MN B XXXXXXXXXX XXXXXXXXXX

MDBXXXXXXXXXXXXXXXXX

06/2007

[ 2]

High Voltage

[ 7]

Film Changer

DEVICE

XXXXXXXXXX XXXXXXXXXX XXXXXXXXXXX

XXX

 

 

 

 

Holder

 

 

 

 

 

 

 

 

Generator

 

 

 

 

MN

 

MD

 

 

[ 3]

Vertical Cassette

[ 8]

Image Intensifier

 

 

MN

 

MD

 

 

[ 4]

Tube Housing

[ 9]

Spot Film Device

 

 

MN

 

MD

 

 

 

 

 

 

 

 

 

Assembly

 

 

 

 

 

 

 

 

 

[ 5]

Dental Tube Head

[10]

Fluoroscopic

TABLES

 

MANUFACTURER

 

MODEL NUMBER

DATE MFR'ED

 

 

 

 

Device

 

Imaging Assembly

 

MN

 

MD

 

 

 

 

 

 

 

MN T

 

MD T

06/2007

[11]

Cephalometric

[12]

Image Receptor

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[13]

Image Receptor

[14]

Fluorocopic Air

CT GANTRY

MANUFACTURER

 

MODEL NUMBER

DATE MFR'ED

 

 

[15]

Other: Other component

Kerma Display

 

 

 

 

 

 

 

 

 

Support Device

 

 

 

MN C

 

MD C

06/2007

 

 

 

 

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

John Smith

SIGNATURE

DATE

06/30/2008

6. COMMENTS

Comments....

Line 2

Line 3

Line 4

Line 5

Line 6

Line 7

Line 8

Line 9

Line 10

Fda 2579 Form isn’t the one you’re looking for?

Related Documents