Duns Number:534155155
Device Description: "Omnisense 7000:The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultraso "Omnisense 7000:The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. It is comprised of a Main Unit and small hand held probes, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia.Reference databases are provided for measurements at each of the skeletal sites.Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated.Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young adults), Z-score values (units of standard deviations relative to age and gender matched population reference values), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Omnisense may report the Osteoporosis, Risk Index (ORI™), which combines the individual results into a single clinical index.No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device.Probes:Omnisense is a multiple skeletal sites. The probes designed to support measurement at the following areas:• CM probe - used for bone strength assessment at the radius and tibia• CS probe - used for bone strength assessment at the phalanx• CR probe - used for bone strength assessment at the metatarsalThe probes can be supplied with Omnisense 7000 and/or Omnisense 8000.Omnisense models:S – Adult applicationP – Pediatric application Premier - Premature
Catalog Number
-
Brand Name
BeamMed
Version/Model Number
OMNISENSE 7000 ULTRASOUND BONE SONOMETER
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
MUA
Product Code Name
Bone Sonometer
Public Device Record Key
2b3bffbb-8cf1-430c-a077-01a885915683
Public Version Date
July 08, 2020
Public Version Number
5
DI Record Publish Date
January 25, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |