Identifiers
- 510(k) Number
- K243240 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Vitrea CT VScore is an advanced visualization application designed for use with computed tomography imaging. It provides clinical tools for the analysis of medical images.
This software application is supplied by Canon Medical Informatics, Inc. It has received FDA 510(k) clearance for clinical use. Users should refer to the provided instructions for use for complete information regarding its application.
Frequently asked questions
What is the primary purpose of Vitrea CT VScore?
Vitrea CT VScore is a specialized visualization application developed to provide clinicians with advanced tools for the analysis of computed tomography (CT) imaging data.
Has this software received regulatory authorization?
Yes, Vitrea CT VScore has received FDA 510(k) clearance for clinical use, confirming it has been reviewed and found substantially equivalent to existing devices.
Where can I find detailed instructions for using this application?
Users should consult the official instructions for use provided by Canon Medical Informatics, Inc. for comprehensive information regarding the application's clinical functions and operational guidelines.
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: CT VScore | Clinical Application Video | Clinical Applications ..., Vitrea Advanced Visualization for CT | Canon Medical Systems USA, CT VScore™ | Healthcare IT | Canon Medical Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243240 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Medical Informatics, Inc.
Sources (1)
- FDA 510(k) K243240 24 fields · synced Oct 6, 2026