Code of Federal Regulations Title 21. Food and Drugs § 21.892.1715 Full-field digital mammography system

(a) Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document:  Full–Field Digital Mammography System.” See § 892.1(e) for the availability of this guidance document.