21 CFR 892.1170 — Densitometer, Bone
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1170
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KGI | Densitometer, Bone | 2 | 146 | 3rd Party |
