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Report of Assembly (ROA)

Handler/Assembler/Maintainer of Radiation-Generating Equipment Reporting Requirements

Any handler that assembles, installs, de-installs or disposes of radiation-generating equipment (RGE) within the State of Ohio shall notify the director, in writing, at least quarterly of such actions.  These reports provide essential information that allow the Ohio Department of Health (ODH) to research and track RGE. Sellers of RGE to customers in Ohio may also use the FDA for 2579 for reporting.  The information provided is used to determine if the new location has a valid registration and help to ensure compliance with all Ohio Rule and Code.

Each report shall contain:

• Assembler Information:

  • Company Name
  • Address
  • City, State, Zip code
  • Telephone number and contact name
  • Registration #

• Facility that received the equipment:

  • Facility Name
  • Address
  • City, State, Zip code
  • Telephone number and contact name
  • Registration #

• Date of assembly/sale/transfer/disposal/installation:

• Type of equipment:

  • x-ray equipment type name
  • new or reassembly
  • stationary or mobile
  • master control room
  • manufacturer
  • model #
  • serial #

Reports of Assembly are to be submitted at least quarterly to X-ray Registration via e-mail xrayreg@odh.ohio.gov or fax (614) 644-8526 

The state copy of the United States Department of Health and Human Services, Food and Drug Administration "Report of Assembly of a Diagnostic X-ray System" Form 2579, used for reporting diagnostic x-ray systems which contain certified components, may be used to meet the notification requirements.

Reports must be submitted to the State of Ohio X-ray Registration at least quarterly and must contain the name and address of the facility that received equipment; the manufacturer, model, and serial number of the x-ray tube or x-ray generator transferred, disposed of, or installed; and the date of transfer, disposal, or installation of the radiation-generating equipment.

You can request blank Food and Drug Administration "Report of Assembly of a Diagnostic X-ray System" Form 2579 from the FDA at FormsManager@OC.FDA.GOV

Diagnostic X-ray Reports of Assembly (ROA)

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 FDA 2579) represents the assemblers’ certification that the system or component(s) are of the type called for by the Standard (i.e., certified), have been assembled according to the instructions provided by the manufacturer, and meets the requirements of the applicable Federal standards contained in 21 CFR 1020.30 through 1020.33. Reports must be provided to the purchaser and filed with FDA's Center for Devices and Radiological Health (CDRH) within 15 days of completion of the assembly.  Copies must likewise be provided to the State of Ohio quarterly to xrayreg@odh.ohio.gov

If you assemble, install, de-install, dispose, service, handle or possess x-ray equipment in the State of Ohio you must have a current, valid registration.