Radiation-Emitting Products

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?

Policy Guidance Help System logo

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

Page Last Updated: 07/24/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.