21 C.F.R. § 892.1710

Mammographic x-ray system.

Last amended: 2016Year: 2026Length: 43 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 892.1710 (2026)

(a) Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. (b) Classification. Class II.
21 C.F.R. § 892.1710: Mammographic x-ray system. | Justis AI