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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namebone sonometer
Generic Namequantitative ultrasound (qus) for bone assessment
Regulation Number892.1180
PMA NumberP970026
Date Received07/01/1997
Decision Date05/29/1998
Reclassified Date 08/18/2008
Product Code
MUA[ Registered Establishments with MUA ]
Docket Number 98M-0722
Notice Date 09/09/1998
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Perform quantitative ultrasound measurement of tibia (shin bone), the results of which can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone strength and ultimately, in the determination of fracture risk. The soundscan measures the velocity ofultrasound (speed of sound, sos, in m/sec) along the tibia, exclusivey within bone, unaffected by overyling soft tissue. Sos along the tibia provides an index of bone strength, with stronger bone having higher velocities. As such the soundscan provides a measure of skeletal fragility. The soundscan reports sos along with both t- and z-scores.