DeviceClearance

Product code MUA— Radiology

ACHILLES

Classification name
Bone Sonometer
Device class
Class 2
Regulation
21 CFR 892.1180
Advisory panel
Radiology
Total cleared
9
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code MUA under 21 CFR 892.1180, via openFDA

Market context for product code MUA

FDA has cleared 9 devices under product code MUA between 2011 and 2022, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MUA

Recent clearances under product code MUA

Data sourced from openFDA. This site is unofficial and independent of the FDA.