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Device | UBIS 5000 BONE SONOMETER |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | DIAGNOSTIC MEDICAL SYSTEMS DISTRICT DE MONTPELLIER, PEROLS 34470 |
PMA Number | P000055 |
Date Received | 12/18/2000 |
Decision Date | 07/17/2001 |
Reclassified Date
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08/18/2008 |
Product Code |
MUA |
Docket Number | 01M-0360 |
Notice Date | 08/23/2001 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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