UBIS 5000 BONE SONOMETER
FDA premarket approval P000055 · decided 2001-07-17
Approval details
- PMA number
- P000055
- Trade name
- UBIS 5000 BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Diagnostic Medical Systems
- Date received
- 2000-12-18
- Decision date
- 2001-07-17
- Days to decision
- 211 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Perols
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EXPLORER CVS TRANSCRANIAL DOPPLER (K990517) | Diagnostic Medical Systems | 2000-08-01 |