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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceDTU-ONE ULTRASOUND SCANNER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantOSTEOMETER MEDITECH A/S
1, KOGLE ALLE
HORSHOLM DK-29-2970
PMA NumberP980010
Date Received04/15/1998
Decision Date09/19/2000
Reclassified Date 08/18/2008
Product Code MUA 
Docket Number 00M-1615
Notice Date 11/15/2000
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DTU-ONE ULTRASOUND SCANNER. THE DTU-ONE IS INTENDED TO PERFORM QUANTITATIVE ULTRASOUND MEASUREMENT OF THE CALCANEUS (THE HEEL BONE), THE RESULTS OF WHICH CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN DIAGNOSIS OF OSTEOPOROSIS (T-SCORE) AND IN THE DETERMINATION OF FRACTURE RISK IN MEN AND WOMEN. THE MEASUREMENT MAY ALSO BE USED IN CAUCASIAN WOMEN TO AID IN THE DETECTION OF MEDICAL CONDITIONS, OTHER THAN AGE-RELATED BONE LOSS, THAT LEAD TO REDUCED BONE DENSITY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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