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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameUBIS 5000 BONE SONOMETER
Classification Namebone sonometer
Generic Namebone sonometer
Regulation Number892.1180
ApplicantDIAGNOSTIC MEDICAL SYSTEMS
PMA NumberP000055
Date Received12/18/2000
Decision Date07/17/2001
Reclassified Date 08/18/2008
Product Code
MUA[ Registered Establishments with MUA ]
Docket Number 01M-0360
Notice Date 08/23/2001
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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