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U.S. Department of Health and Human Services

Radiation-Emitting Products

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If we have multiple S-F units and plan to use CR with all of them, do we need approval to extend our certification to add CR to all of them?

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Yes. Since FDA grants certification extension for the use of a CR system only with a specific mammography unit, the additional units are not covered even if they are the same make and model.

Back to Full Field Digital Mammography (FFDM) Certification Extension Program