CA Clarifies Accreditation Requirements for Koning Breast CT Units

The California Department of Public Health (CDPH) clarified its position regarding accreditation requirements for Koning Breast CT units and updated its mammography facilities guidance. While California law requires CT X-ray systems to be accredited by approved organizations, the state relies on the U.S. Food and Drug Administration’s (FDA) product classification to determine whether a particular device falls within the scope of that requirement and distinction is made between general descriptions of CT X-ray systems and the specific device classification/intended use.

Based on clarification received from the FDA, CDPH determined that the Koning Breast CT unit is not subject to California’s CT accreditation requirement and the CDPH has removed website language suggesting otherwise. ACR^® appreciates CDPH’s prompt review and the agency’s updated guidance. Additional questions or inquiries can be directed to RHBRMT@cdph.ca.gov.

For information on state legislation or ACR state resources, contact Eugenia Brandt, ACR Senior Government Relations Director.