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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/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.
 
DeviceTHE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantBEAM-MED LTD
8 HALAPID STR.
PETACH TIKVA 49170
PMA NumberP990035
Date Received06/30/1999
Decision Date01/20/2000
Reclassified Date 08/18/2008
Product Code MUA 
Docket Number 00M-0577
Notice Date 02/16/2000
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Sumlight Omnisense Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the velocity of ultrasound waves ("Speed of Sound" or "SOS in m/sec") propagating along the distal one-third of the radius bone. SOS provides a measure of skeletal fragility. The output is also expressed as a T-score and Z-score and can be used in conjunction with other clinical risk factors as an aid to the physician in diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a pateints' measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S005 S001 S006 S002 S003 S004 
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