Identity
- Trade Name
- BeamMed FDA UDI
- Generic Name
- Bone absorptiometric ultrasound system FDA UDI
- Device Name
- "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 metatarsal The probes can be supplied with Omnisense 7000 and/or Omnisense 8000. Omnisense models: S – Adult application P – Pediatric application Premier - Premature FDA UDI
- Model / Reference
- OMNISENSE 7000 ULTRASOUND BONE SONOMETER FDA UDI
- Description
- "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 metatarsal The probes can be supplied with Omnisense 7000 and/or Omnisense 8000. Omnisense models: S – Adult application P – Pediatric application Premier - Premature FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07299012704119 FDA UDI
- FDA Product Code
- MUA FDA UDI
- GMDN Term
- Bone absorptiometric ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1180 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
BeamMed by Beam-Med, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beam-Med, Ltd.
Sources (1)
- FDA UDI 2b3bffbb-8cf1-430c-a077-01a885915683 34 fields · synced May 30, 2026