21 CFR § 892.1170 Radiology Devices

§ 892.1170 Bone densitometer.

Current through Sep 8, 2026 · Read all of Part 892

⚠ 3 pending changes to Part 892

(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.

← § 892.1130 Nuclear whole body counter.§ 892.1180 Bone sonometer. →