Vitrea CT Cardiac Analysis
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222662 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vitrea CT Cardiac Analysis is a Cardiac Imaging Software designed for post-processing and advanced analysis of computed tomography (CT) scans of the heart. It provides quantitative assessment of cardiac structures, coronary arteries, and perfusion, enabling clinicians to evaluate coronary artery disease, myocardial viability, and functional parameters such as ejection fraction and myocardial perfusion defects.
This software is intended for use in radiology and cardiology settings, typically integrated into existing CT imaging workflows. Supplied as a standalone application, it requires compatibility with DICOM-compatible CT scanners and workstations. The device is classified under FDA 510(k) clearance (K222662) and MDR, with no explicit sterility or single-use requirements, as it operates as a digital analysis tool. No MRI safety classifications or physical size specifications are provided.
Frequently asked questions
What clinical assessments can the Vitrea CT Cardiac Analysis software perform on CT scans of the heart?
The Vitrea CT Cardiac Analysis software is designed to provide quantitative evaluations of cardiac structures, coronary arteries, and myocardial perfusion. Clinicians can use it to assess coronary artery disease, determine myocardial viability, and measure functional parameters such as ejection fraction and myocardial perfusion defects. This makes it particularly useful for detailed cardiac analysis in radiology and cardiology settings.
How is the Vitrea CT Cardiac Analysis software supplied, and what system compatibility does it require?
The Vitrea CT Cardiac Analysis is supplied as a standalone software application. It requires compatibility with DICOM-compatible CT scanners and workstations to integrate seamlessly into existing imaging workflows. Since it operates digitally, no physical hardware or sterility requirements apply.
Is the Vitrea CT Cardiac Analysis software intended for single-use or repeated use in clinical settings?
The Vitrea CT Cardiac Analysis is not a single-use device—it is a digital analysis tool designed for repeated use in radiology and cardiology workflows. As a software application, it can be utilized across multiple CT scans and patient evaluations without replacement.
What regulatory pathways does the Vitrea CT Cardiac Analysis follow, and how was its equivalence determined?
The Vitrea CT Cardiac Analysis follows both FDA 510(k) clearance (K222662) and MDR (Medical Device Regulation) pathways. Its substantial equivalence was determined through a review by the FDA’s Radiology Advisory Committee (RA), where it was classified under product code LLZ and deemed substantially equivalent to a predicate device.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222662 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Medical Informatics, Inc.
Sources (2)
- FDA 510(k) K222662 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026