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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSAHARA CLINICAL BONE SONOMETER
Classification Namebone sonometer
Generic Nameacoustic bone densitometer
Regulation Number892.1180
ApplicantHOLOGIC, INC.
PMA NumberP970017
Date Received04/07/1997
Decision Date03/12/1998
Reclassified Date 08/18/2008
Product Code
MUA[ Registered Establishments with MUA ]
Docket Number 98M-0187
Notice Date 04/16/1998
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sahara clinical bone sonometer. The intended use of the sahara clinical bone sonometer is to: perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clincal risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the determination of fracture risk. Sahara measures the speed of sound (sos, in m/s) and broadband ultrasonic attenuation (bua, in db/mhz) of an ultrasound beam passed throught he calcaneus, and combines these results linearly to obtain the quantitative ultrasound index (qui). The output is also expressed as a t-score and as an estimate of the bone mineral density (bmd, in g/cm2) of the calcaneus as measured by dual energy x-ray absorpiometry (dxa).
Supplements: S001 
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