DTU-ONE ULTRASOUND SCANNER
FDA premarket approval P980010 · decided 2000-09-19
Approval details
- PMA number
- P980010
- Trade name
- DTU-ONE ULTRASOUND SCANNER
- Generic name
- Bone sonometer
- Applicant
- Osteometer Meditech A/S
- Date received
- 1998-04-15
- Decision date
- 2000-09-19
- Days to decision
- 888 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Horsholm
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DTX-200 BONE DENSITOMETER (K964562) | Osteometer Meditech A/S | 1997-08-22 |
| DTX-100 BONE DENSITOMETER (K963789) | Osteometer Meditech A/S | 1997-07-14 |