FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Bone Sonometer
PMA: P000055
·
Decision Jul 17, 2001
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- UBIS 5000 BONE SONOMETER
- PMA Number
- P000055
- Device Class
- FDA Class 2
- Product Code
- MUA
- Generic Name
- Bone sonometer
- Regulation Number
- 892.1180
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- July 17, 2001
- Date Received
- December 18, 2000
- Expedited Review
- N
- Docket Number
- 01M-0360
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUA | Bone Sonometer | FDA class 2 | Radiology |