Bone Sonometer
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
- PMA Number
- P990035
- 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
- January 20, 2000
- Date Received
- June 30, 1999
- Expedited Review
- N
- Docket Number
- 00M-0577
Advisory Committee Statement
The Sumlight Omnisense Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the velocity of ultrasound waves ("Speed of Sound" or "SOS in m/sec") propagating along the distal one-third of the radius bone. SOS provides a measure of skeletal fragility. The output is also expressed as a T-score and Z-score and can be used in conjunction with other clinical risk factors as an aid to the physician in diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a pateints' measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).
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 |