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).
| Device | THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER |
| Classification Name | Bone Sonometer |
| Generic Name | Bone Sonometer |
| Applicant | BEAM-MED LTD |
| Date Received | 1999-06-30 |
| Decision Date | 2000-01-20 |
| Notice Date | 2000-02-16 |
| PMA | P990035 |
| Supplement | S |
| Product Code | MUA |
| Docket Number | 00M-0577 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BEAM-MED LTD 8 Halapid Str. petach Tikva 49170 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990035 | | Original Filing |
| S006 |
2002-11-01 |
Normal 180 Day Track |
| S005 |
2001-12-21 |
Normal 180 Day Track |
| S004 |
2001-09-25 |
Normal 180 Day Track |
| S003 |
2001-08-10 |
Normal 180 Day Track |
| S002 |
2001-06-26 |
Normal 180 Day Track |
| S001 |
2000-06-26 |
Normal 180 Day Track |
NIH GUDID Devices