Sunlight Omnisense Ultrasound Bone Sonometer
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER FDA PMA
- Generic Name
- Bone sonometer FDA PMA
Identifiers
- PMA Number
- P990035 FDA PMA
- FDA Product Code
- MUA FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.1180 FDA PMA
- Regulation Number
- 892.1180 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive diagnostic device classified as a bone sonometer. It measures the velocity of ultrasound waves (Speed of Sound, or SOS in meters per second) along the distal one-third of the radius bone, providing quantitative assessment of skeletal fragility. The device outputs SOS values alongside T-scores and Z-scores to aid physicians in diagnosing osteoporosis and related conditions affecting bone strength. These measurements help evaluate fracture risk, particularly in postmenopausal women aged approximately 50 to 65 years.
This device is used in radiology settings for clinical monitoring of bone changes over time. It is supplied as a reusable medical instrument and has received FDA Premarket Approval under PMA number P990035. The Omnisense operates within the regulatory framework of Class II (device class 2) under regulation number 892.1180, with multiple registration and FEI numbers recorded. No sterility or single-use specifications are indicated in the provided data.
Frequently asked questions
What clinical conditions is the Sunlight Omnisense Ultrasound Bone Sonometer primarily used to evaluate in patients?
The Sunlight Omnisense Ultrasound Bone Sonometer is designed to assess skeletal fragility by measuring the speed of sound (SOS) along the distal one-third of the radius bone. It provides quantitative data in the form of T-scores and Z-scores to aid physicians in diagnosing osteoporosis and related conditions that reduce bone strength. This helps evaluate fracture risk, particularly in postmenopausal women aged approximately 50 to 65 years.
Is the Sunlight Omnisense Ultrasound Bone Sonometer intended for single-use or reusable applications, and how should it be maintained?
The Sunlight Omnisense Ultrasound Bone Sonometer is supplied as a reusable medical instrument. Since no sterility specifications are indicated, maintenance should follow manufacturer guidelines for cleaning and disinfection to ensure proper functionality and patient safety between uses.
What type of regulatory approval does the Sunlight Omnisense Ultrasound Bone Sonometer hold, and where is it primarily used in clinical settings?
The device holds FDA Premarket Approval (PMA) under PMA number P990035, classifying it as a Class II medical device under regulation number 892.1180. It is primarily used in radiology settings for clinical monitoring of bone changes over time, particularly for evaluating fracture risk in patients with osteoporosis.
How does the Sunlight Omnisense Ultrasound Bone Sonometer help in monitoring bone health over time, and for which patient population is it most suitable?
The device measures the speed of sound (SOS) along the radius bone, providing precise T-scores and Z-scores that reflect skeletal fragility. Its precision error is low enough to detect early bone changes post-menopause, making it suitable for monitoring bone health in women aged approximately 50 to 65 years. This aids in assessing fracture risk and tracking progression or improvement in bone strength over time.
What specific measurements does the Sunlight Omnisense Ultrasound Bone Sonometer provide, and how are these used in clinical practice?
The device outputs the speed of sound (SOS) in meters per second along the distal one-third of the radius, alongside T-scores and Z-scores. These measurements quantify bone density and skeletal fragility, helping clinicians diagnose osteoporosis and related conditions. The SOS values, combined with T-scores and Z-scores, assist physicians in assessing fracture risk and making informed decisions about patient care.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990035 | Class II | Active |
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Manufacturer
- Manufacturer
- Beam-Med, Ltd.
Sources (1)
- FDA PMA P990035 24 fields · synced Sep 18, 2026