MUA

9 FDA 510(k) clearances · Product code

FDA profile

Official device name

Bone Sonometer

Device class

Class II (moderate risk)

Regulation

21 CFR 892.1180

Medical specialty

Radiology

FDA definition

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. Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers

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