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?
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
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