• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namebone sonometer
Generic Namebone sonometer
Regulation Number892.1180
35 crosby dr.
bedford, MA 01730
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