MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
FDA premarket approval P970026 · decided 1998-05-29
Approval details
- PMA number
- P970026
- Trade name
- MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
- Generic name
- Bone sonometer
- Applicant
- Myriad Ultrasound Systems , Ltd.
- Date received
- 1997-07-01
- Decision date
- 1998-05-29
- Days to decision
- 332 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Rehovot
- 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 pro
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