THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
FDA premarket approval P990035 · decided 2000-01-20
Approval details
- PMA number
- P990035
- Trade name
- THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Beam-Med, Ltd.
- Date received
- 1999-06-30
- Decision date
- 2000-01-20
- Days to decision
- 204 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Petach Tikva
- 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 condit
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (K110646) | Beam-Med, Ltd. | 2011-10-12 |