FDA Product Code MUA: Bone Sonometer
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
Leading manufacturers include Echolight S.P.A and Bone Index Finland , Ltd..
FDA 510(k) Cleared Bone Sonometer Devices (Product Code MUA)
About Product Code MUA - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code MUA since 2011, with 9 receiving FDA clearance (average review time: 224 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
MUA devices are reviewed by the Radiology panel. Browse all Radiology devices →