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X-Ray Assembler Data

Online Database

General Information

Federal regulations (Section 21 CFR 1020.30(d)) require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly.  The report constitutes the assembler's certification that the components installed are of the type called for by regulations, and that the components were assembled, installed, adjusted, and tested in accordance with the manufacturer's instructions and meet all applicable performance requirements.

FDA uses these reports to locate and identify systems for routine compliance testing at the user facility. This is mandated under Subchapter C - Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968) of Chapter V of the Federal Food, Drug and Cosmetic Act (Act). Most of the data is considered confidential since it would involve assembler customer lists, and manufacturer sales and distributions information. The Assembler Database available here contains the releasable information submitted on form FDA 2579 (Block 1 - Equipment Location, Block 3 - General Information and Block 4(h)  - under Component Information)  Note: Data does not include dental system installations. The database covers installation dates from January 1987 to December 2001.  

Data Availability

You can search the Assembler Database by name, state, use, or a range of installation dates. A search query on the database will produce results in the following format:

Name
Address
City
State
Zip
Phone
Date Installed
Location Installed
Type (Stationary or Mobile)
Use
Component

The Assembler Database is updated on an annual basis and records are current through 2000..  

Assembler Data Zip Files

The Assembler data is also available for downloading as a zip file. 

  1. uncompress the file with WinUnzip, PKUnzip, or other utility;
  2. If the file is to be imported into a database, the end-of-record marker is the CRLF (carriage return line feed) symbol

ASSEM.ZIP  (10 MB zipped, 29 MB unzipped, 238,807 records) 

Each record consists of fields separated by a | and is in the following format:

Name
Address
City
State
Zip
Phone
Installed Date
Room
Use (up to four sets of  codes)
Type (Stationary or Mobile)
Component (up to nine letter codes)

Use Codes

1 GENERAL PURPOSE RADIOGRAPHY
2 GENERAL PURPOSE FLUOROSCOPY
4 TOMOGRAPHY (OTHER THAN CT)
5 ANGIOGRAPHY
6 PODIATRY
7 UROLOGY
8 MAMMOGRAPHY
9 CHEST
10 HEAD - NECK
11 OTHER (NON DENTAL)
12 DENTAL PANORAMIC
13 DENTAL - INTRAORAL
14 DENTAL - CEPHALOMETRIC
16 CT - HEAD SCANNER
17 CT - WHOLE BODY SCANNER
18 CHIROPRACTIC
19 RADIATION THERAPY SIMULATOR
60 C-ARM FLUOROSCOPIC
70 DIGITAL
80 MOBILE OR PORTABLE
81 MAY BE INSTALLED AS EITHER
20 BONE MINERAL ANALYSIS MOBILE OR STATIONARY EQUIPMENT

Component Type Codes

I FLUOROSCOPIC IMAGING ASSEMBLY
S SPOT FILM DEVICE
B TUBE HOUSING ASSEMBLY
H HIGH VOLTAGE GENERATOR
F X-RAY CONTROLS
L CASSETTE HOLDERS
K CRADLE
M FILM CHANGER
O OTHER

Updated March 9, 2004

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