(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]