Beammed Sunlight Miniomni Bone Sonometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110646 FDA 510(k)
- FDA Product Code
- MUA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1180 FDA 510(k)
- Regulation Number
- 892.1180 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Beammed Sunlight Miniomni Bone Sonometer is a diagnostic ultrasound device classified as a bone sonometer, designed to measure bone density and assess skeletal integrity. It operates using ultrasound technology to evaluate bone quality, aiding in the diagnosis and monitoring of conditions such as osteoporosis or other metabolic bone diseases.
This device is intended for use in radiology settings and is supplied as a reusable medical instrument. Authorized under FDA 510(k) clearance and MDD compliance, it is classified as a Class II device (Device Class 2) under regulation 892.1180. Sterility and MRI safety specifications are not explicitly stated in the provided data, but it is regulated for clinical diagnostic applications in radiology.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K110646 | Class II | Active |
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Manufacturer
- Manufacturer
- Beam-Med, Ltd.
Sources (2)
- FDA 510(k) K110646 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026