(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 Sec. 892.1(e) for the availability of this guidance document. [73 FR 40969, July 17, 2008]