Bone Sonometer
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
- PMA Number
- P970026
- 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
- May 29, 1998
- Date Received
- July 1, 1997
- Expedited Review
- N
- Docket Number
- 98M-0722
Advisory Committee Statement
Perform quantitative ultrasound measurement of tibia (shin bone), the results of which can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone strength and ultimately, in the determination of fracture risk. The SoundScan measures the velocity ofultrasound (speed of sound, SOS, in m/sec) along the tibia, exclusivey within bone, unaffected by overyling soft tissue. SOS along the tibia provides an index of bone strength, with stronger bone having higher velocities. As such the SoundScan provides a measure of skeletal fragility. The SoundScan reports SOS along with both T- and Z-scores.
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 |