Can a facility use lossy compression to store FFDM images for retention purposes?
No. Currently FDA does not permit images regenerated from lossy compressed data to be used in the same manner as the original mammogram. Question 9: Can a facility use lossy compression to recreate FFDM images for final interpretation? No. Currently FDA does not permit images regenerated from lossy compressed data to be used in the same manner as the original mammogram. While not allowed for final interpretation, lossy compressed 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 lossy compressed images are used for comparison purposes that only algorithms 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 lossy compression pass all applicable quality control tests and be of such quality that if t
