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radiologic health branch (RHB)

Radiation Machine Vendor Reporting Obligations

Title 17, California Code of Regulations (17 CCR), section 30118ā€‹, requires that any manufacturer, distributor, retailer, agent, or any other person who sells, leases, transfers, or lends a radiation machine to any person who is required to register such machine shall notify the RHB no later than 30 days after the end of each calendar quarter of: 
(1) The names and addresses of persons who have received such machines 
(2) The manufacturer and model of each machine
(3) The date of transfer of each radiation machine
(4) Other related information as may be required by the Department.  

This notification can be submitted via email to XrayRegistration@cdph.ca.gov. Reporting may be done by submitting copies of the FDA 2579 form. Spreadsheet formats containing the above required information are also acceptable.

Section 30118 also requires that vendors inform the receiver of the radiation machine of the registration requirements of 17 CCR, section 30108ā€‹, which requires every person possessing a reportable source of radiation to register with the Department. Vendors may direct persons receiving radiation machines to the CDPH-RHB X-ray machine registration portal

Vendor reporting to meet section 30118 obligations does NOT ā€‹satisfy registrant radiation machine reporting requirements under section 30108.

Vendors may furnish reports by emailing us or by USPS: 
ā€‹ā€‹USPS Mailing Address:ā€‹  
California Department of Public Health 
Radiologic Health Branch
P.O. Box 997414, MS 7610 
Sacramento, CA 95899-7414

Physical Address (for FEDEX, UPS, etc.)ā€‹
California Department of Public Health 
Radiologic Health Branch
1500 Capitol Avenue, 5th Floor, MS 7610 
Sacramento, CA 95814-5006ā€‹
ā€‹ā€‹Demoā€™s & Temporary X-ray Machine Registration
Temporary X-ray Machine Registration for radiation machines may be available under limited and specific circumstances, and subject to RHB approval. Temporary Use Approval allows an entity to meet 17 CCR, section 30108 registration requirements for a maximum of 7 calendar days, starting from the first date the machine is energized in California. Notification must be provided to CDPH-RHB at least 14 days prior to the date the machine(s) are first energized. Temporary use approval is identical to the typical radiation machine registration and requires that all other obligations and compliances still be met. 

Temporary X-ray Machine Registration is intended for demonstration purposes and certain short-term projects. 

Temporary X-ray Machine Registration is not eligible for:
  • Mobile X-ray Service Providers
  • Loaned Equipment for Non-Demonstration Use
  • Mammography Machines
  • Therapeutic Machines

To apply, submit the following information to RHBXRayInspectionChief@cdph.ca.gov:
  • Company Name
  • Address(es) where machine(s) will be energized
  • Dates when machines will be energized
  • Machine manufacturer, model, & number of tubes
  • Total Number of Units
  • Intended use of machine(s) 
  • If machine(s) will be energized for non-demonstrative purposes, a description of the project or reason the radiation machine(s) will be utilized. 
ā€‹Temporary Use Approval is not subject to fees at this time.

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