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U.S. Department of Health and Human Services

Radiation-Emitting Products

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How are additional mammography reviews (AMR) different from the reviews that are performed for accreditation, reaccreditation, or random clinical image review?

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AMRs are performed in cases where FDA or the Certifying State has reason to believe that mammography quality has been compromised and may present a serious risk to human health. An example of such a circumstance might be the detection of a Level 1 phantom image failure during an inspection. Accreditation bodies do not use the clinical image reviews (CIRs) performed during accreditation, re-accreditation, and random clinical image review to investigate possible problems at facilities. Accreditation bodies use these types of CIRs to evaluate the ongoing quality of mammography at all facilities.

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