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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceUBIS 5000 BONE SONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantDIAGNOSTIC MEDICAL SYSTEMS
DISTRICT DE MONTPELLIER,
PEROLS 34470
PMA NumberP000055
Date Received12/18/2000
Decision Date07/17/2001
Reclassified Date 08/18/2008
Product Code MUA 
Docket Number 01M-0360
Notice Date 08/23/2001
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE UBIS 5000. THE UBIS 5000 IS A QUANTITATIVE ULTRASOUND (AUS) BONE SONOMETER AND IS INDICATED FOR THE MEASUREMENT OF BROADBAND ULTRASOUND ATTENUATION (BUA) OF THE CALCANEUS, AS AN AID TO DIAGNOSE OSTEOPOROSIS AND TO ESTIMATE THE RISK OF SUBSEQUENT ATRAUMATIC FRACTURE. THE OUTPUT IS EXPRESSED IN TERMS OF BOTH BUA AND T-SCORE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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