MUA · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1180
Classification
FDA Product Code
MUA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.1180
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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