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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.
 
DeviceQUS-2 (TM) CALCANEAL ULTRASONOMETER
Generic NameTester, acoustic, bone quality
ApplicantQUIDEL CORP.
2981 COPPER RD.
SANTA CLARA, CA 
PMA NumberP990039
Date Received07/14/1999
Decision Date08/01/2000
Withdrawal Date 10/08/2010
Product Code NAN 
Docket Number 00M-1437
Notice Date 08/16/2000
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE QUS-2 CALCANEAL ULTRASONOMETER. THE QUS-2 ULTRASONOMETER IS A MEDICAL DEVICE THAT UTILIZES QUANTITATIVE ULTRASOUND FOR EVALUATION OF THE CALCANEUS. ITS BUA (BROADBAND ULTRASOUND ATTENUATION) VALUE IS INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF OSTEOPOROSIS AND IN THE DETERMINATION OF RISK OF SUBSEQUENT ATRAUMATIC FRACTURE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
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