Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Bone Sonometer

FDA product code MUA · 9 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1180
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-05-11 – 2022-04-29

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

↑