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 the present.
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:
- Date Installed
- Location Installed
- Type (Stationary or Mobile)
Assembler Data Zip Files
The Assembler data is also available for downloading in three zip files:
- uncompress the files with WinUnzip, PKUnzip, or other utility;
- If the files are to be imported into a database, the end-of-record marker is the CRLF (carriage return line feed) symbol
Each file consists of fields separated by a | and is in the format below. The files are linked by their ID number.
Assembler Equipment Locations
(1=used, 0=not used)
Assembler Use Codes
(Y=used, N=not used)
- XRAYSYSTEMMOBILITY S=Stationary M=Mobile