21 CFR § 892.1170 - Bone densitometer.

---
identifier: "/us/cfr/t21/s892.1170"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1170 - Bone densitometer."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1170"
section_name: "Bone densitometer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 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.