X-Ray Installers

Installer Responsibilities/Guidance?

Registered installers and service providers must comply with all applicable state and federal requirements.

1. Registration of Equipment

• Only the client (registrant) may register their X-ray equipment — not the installer.

2. Documentation of Installations and Removals

• Installers must provide a written record of each radiation unit removed, transferred, or installed.
• Quarterly reporting is required by State Regulations for Protections Against Radiation (SRPAR 0400-20-10-.25). However, reports may be submitted more frequently (e.g., monthly or as completed).
• Documentation may be submitted to xray.registration@tn.gov

3. Receipts

• Upon installation, the installer must provide a receipt to the provider (registrant).

4. FDA (Food and Drug Administration) 2579 Form – Report of Assembly

• Installers are required to complete an FDA Form 2579 — Report of Assembly of a Diagnostic X-ray System — for each system assembled or installed. This is a federal requirement under 21 CFR (Code of Federal Regulations) 1020.30(d).
• The form must be completed and distributed as follows:
  • One copy sent to the State agency responsible for radiation protection
  • One copy provided to the Client/Registrant
  • One copy retained by the Installer
• Installers must also comply with all other FDA reporting requirements.
• Access the FDA 2579 Form and Instructions

5. Provide Clients with the “You the Possessor” Flyer

• This flyer outlines who must register X-ray equipment.
• Installers are encouraged to provide a copy to each registrant/client at the time of installation.

Sell-Only Vendors

Businesses that only sell X-ray equipment within Tennessee — with installations performed by a third party — are also required to register.

• Submit the Service Provider/Installer Registration Form and indicate SELL VENDOR ONLY on the form.
• There is no annual fee associated with this registration type.
• Sell-only vendors must report:
  • The sale of each X-ray unit
  • The name of the installer performing the installation
  • Reports may be emailed to XRay.Registration@tn.gov or submitted directly to the Division contact.
• No formal certificate is issued for sell-only vendor registrations.

Regulatory References

Tennessee Regulations

• SRPAR 0400-20-10-.24 – Registration of Providers and Equipment
• SRPAR 0400-20-10-.25 – Reports of Assembly, Installation, and Transfer of Radiation Machines

Federal Regulations

• 21 CFR 1020.30(d) – Assembler’s Report (FDA Form 2579 requirement)
• 21 CFR 1020.31–1020.33 – Performance standards for diagnostic X-ray systems and components

Completed registration forms or questions may be submitted to XRay.Registration@tn.gov.

Helpful Documents and Links

• X-Ray Installers List
• Registration Handout/Flyer
• Installer Flyer/Pamphlet
• CN Form Application for Service Provider/X-Ray Machine Installer

Completed registration forms or questions may be submitted to XRay.Registration@tn.gov.