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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR892.1180]
See Related Information on Bone sonometer. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 892 -- RADIOLOGY DEVICES

Subpart B--Diagnostic Devices

Sec. 892.1180 Bone sonometer.

(a)Identification . A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.

(b)Classification . Class II (special controls). The special control for this device is FDA's "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers." See 892.1(e) for the availability of this guidance document.

[73 FR 40969, July 17, 2008]

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