Code of Federal Regulations · Section
§ 892.1710 — Mammographic X-ray System
21 C.F.R. § 892.1710
View:
(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.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351