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e-CFR data is current as of October 27, 2020

Title 21Chapter ISubchapter HPart 892Subpart 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.

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