U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA eSubmitter
  4. Diagnostic X-ray Reports of Assembly
  1. FDA eSubmitter

Diagnostic X-ray Reports of Assembly

Manufacturers of diagnostic x-ray systems intended for human use are required to file reports of assembly upon installation of a certifiable system or component(s). The report of assembly (Form 2579) represents the assemblers certification that the system or component(s):

  • are of the type called for by the Standard (that is, certified),
  • have been assembled according to the instructions provided by the manufacturer, and
  • meet the requirements of the applicable Federal standards contained in 21 CFR 1020.30 through 1020.33.

Reports must be provided to the purchaser and, where applicable, to the State agency responsible for radiation protection within 15 days following completion of the assembly of a diagnostic x-ray system. Contact Information for State agencies is available on the website of the Conference of Radiation Control Program Directors (CRCPD), the organization of state radiation regulators. (If the pop-up information block includes "State Medical Contacts", select it and then select the "Form 2579" tab.)

Additional Information:

Back to Top