PMA P970026
- Device
- MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
- Applicant
- Myriad Ultrasound Systems , Ltd.
- PMA number
- P970026
- Product code
- MUA
- Decision date
- 1998-05-29
- Generic name
- Bone sonometer
- Approval order 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.
Current openFDA PMA Record
- Device
- MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
- Applicant
- Myriad Ultrasound Systems , Ltd.
- PMA number
- P970026
- Product code
- MUA
- Generic name
- Bone sonometer
- Decision date
- 1998-05-29
- Decision code
- APRL
- Date received
- 1997-07-01
- Approval order 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.