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Device | DTU-ONE ULTRASOUND SCANNER |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | OSTEOMETER MEDITECH A/S 1, KOGLE ALLE HORSHOLM DK-29-2970 |
PMA Number | P980010 |
Date Received | 04/15/1998 |
Decision Date | 09/19/2000 |
Reclassified Date
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08/18/2008 |
Product Code |
MUA |
Docket Number | 00M-1615 |
Notice Date | 11/15/2000 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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