21 CFR § 892.1170
Bone densitometer
June 25, 2020
(a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) Classification. Class II.