Bone Sonometer

What Is This Device?

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

What Is FDA Product Code MUA?

Bone Sonometer is FDA product code MUA, Class 2, 21 CFR 892.1180.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 140 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2019. None was by a company in China. The root cause the FDA records most often is Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.