Bone Sonometer
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- SAHARA CLINICAL BONE SONOMETER
- PMA Number
- P970017
- 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
- March 12, 1998
- Date Received
- April 7, 1997
- Expedited Review
- N
- Docket Number
- 98M-0187
Advisory Committee Statement
Approval for the Sahara Clinical Bone Sonometer. The intended use of the Sahara Clinical Bone Sonometer is to: Perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clincal risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the determination of fracture risk. Sahara measures the speed of sound (SOS, in m/s) and broadband ultrasonic attenuation (BUA, in dB/MHz) of an ultrasound beam passed throught he calcaneus, and combines these results linearly to obtain the Quantitative Ultrasound Index (QUI). The output is also expressed as a T-score and as an estimate of the Bone Mineral Density (BMD, in g/cm2) of the calcaneus as measured by Dual Energy X-ray Absorpiometry (DXA).
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 |