MUA

Bone Sonometer

Product code

MUA

Device name

Bone Sonometer

Device class

Class 2

21 CFR

21 CFR 892.1180

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).