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e-CFR data is current as of January 15, 2021 |
Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1170 |
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§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.