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 Ge Healthcare, Siemens Medical Solutions USA, Inc. and Fujifilm Medical Systems U.S.A, Inc..