Radiation-Emitting Products

Can a facility use lossy compression to transmit images to the patient or other medical institutions for final interpretation?

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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 transferred to the patient or another medical institution to be used for comparison purposes if the interpreting physician deems that acceptable. However, 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 they were submitted, they would pass the facility’s accreditation body’s phantom and clinical image review process.

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Page Last Updated: 06/26/2014
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