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.
FDA 510(k) Cleared Full Field Digital, System, X-ray, Mammographic Devices (Product Code MUE)
About Product Code MUE - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code MUE since 2011, with 53 receiving FDA clearance (average review time: 182 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
FDA review times for MUE submissions have been consistent, averaging 170 days recently vs 183 days historically.
MUE devices are reviewed by the Radiology panel. Browse all Radiology devices →