FDA Product Code MUE: Full Field Digital, System, X-ray, Mammographic
Under FDA product code MUE, full-field digital mammography systems are cleared for breast cancer screening and diagnostic imaging.
These systems have replaced screen-film mammography as the standard of care, offering superior image quality, lower radiation dose, and the ability to apply digital image processing and AI detection algorithms. They capture digital images of the entire breast in a single compression.
MUE devices are Class II medical devices, regulated under 21 CFR 892.1715 and reviewed by the FDA Radiology panel.
Leading manufacturers include Rayence Co., Ltd., Ge Healthcare and Planmed OY.
List of Full Field Digital, System, X-ray, Mammographic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Full Field Digital, System, X-ray, Mammographic devices (product code MUE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →