Radiation-Emitting Products

Can a facility copy or digitize a film screen mammogram and use that copied or digitized image for retention purposes or final interpretation?

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No. While not allowed for final interpretation, copied or digitized images of previously obtained mammograms may be used for comparison purposes if the interpreting physician deems that acceptable. However, such images cannot be used toward initial or continuing experience requirements.

We recommend that if copied or digitized images are used for comparison purposes that only copiers or digitizers approved or cleared by FDA’s Office of Device Evaluation for such purposes be used. In addition, we recommend that phantom and clinical images produced by such copying or digitization pass all applicable quality control tests and be of such quality that if they were submitted, they would pass the facility’s accreditation body’s phantom and clinical image review process.

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