Identifiers
- 510(k) Number
- K113725 FDA 510(k)
- FDA Product Code
- KGI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1170 FDA 510(k)
- Regulation Number
- 892.1170 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VirtuOst Bone Densitometer is a medical device classified as a bone densitometer, designed to estimate bone mineral density, bone strength, and load-to-strength ratios. It processes data from computed tomography (CT) scans to provide quantitative assessments of bone health, aiding in fracture risk assessment, osteoporosis identification, and therapeutic monitoring. This device leverages existing CT imaging to derive clinically relevant metrics without requiring additional scans, making it a non-invasive diagnostic tool for radiology applications.
The VirtuOst is supplied as a software-based solution integrated with CT imaging systems, intended for use in radiology settings. It is not classified as single-use or reusable but operates as a standalone analytical tool. The device adheres to FDA 510(k) clearance (K113725) under the Radiology advisory committee, with regulatory classification as a Class II device (892.1170). No specific sterility or MRI safety information is provided, and its use is restricted to qualified healthcare professionals for diagnostic interpretation.
Frequently asked questions
What is the VirtuOst Bone Densitometer used for?
The VirtuOst Bone Densitometer is a software-based tool designed to analyze existing CT scan data to estimate bone mineral density, bone strength, and load-to-strength ratios. It helps clinicians assess fracture risk, diagnose osteoporosis, and monitor therapeutic progress without needing additional scans. By leveraging CT imaging, it provides quantitative insights into bone health in radiology settings.
How is the VirtuOst Bone Densitometer supplied and used?
The VirtuOst is supplied as a standalone software solution integrated with CT imaging systems. It is not a physical device but operates as an analytical tool that processes data from CT scans to generate clinically relevant metrics. It is intended for use by qualified healthcare professionals in radiology environments to aid in diagnostic interpretation.
Is the VirtuOst Bone Densitometer single-use or reusable?
The VirtuOst is neither single-use nor reusable in the traditional sense. It is a software-based solution that remains functional as long as it is properly maintained and updated. Since it operates on existing CT imaging systems, its usability depends on the compatibility and performance of the integrated hardware, not on physical disposal or replacement.
Does the VirtuOst Bone Densitometer require sterility or have MRI safety considerations?
The VirtuOst Bone Densitometer is a software-based tool and does not involve physical materials that require sterility. Additionally, no MRI safety information is provided, as the device is designed solely for use with CT imaging systems and does not interact with MRI environments. Its use is restricted to radiology settings where CT scans are performed.
What regulatory approval does the VirtuOst Bone Densitometer hold?
The VirtuOst Bone Densitometer holds FDA 510(k) clearance under the Radiology advisory committee, specifically clearance number K113725. It is classified as a Class II device under the product code 892.1170, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance allows its use in radiology settings for the intended diagnostic purposes.
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. Sources consulted: VIRTUOST by O.N. DIAGNOSTICS | FDA 510 (k) Summary, O N DIAGNOSTICS LLC A VirtuOst - RevMed, O N Diagnostics — Whiteford Research Biobase
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113725 | Class II | Active |
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Manufacturer
- Manufacturer
- O.N. Diagnostics
Sources (1)
- FDA 510(k) K113725 24 fields · synced Oct 1, 2026