Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 892.1170 - Bone densitometer.

(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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
cite as: 21 CFR 892.1170