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Sign in to claim this brandCanon Medical Informatics, Inc.
United States·US-MF-000020013
Last updated September 17, 2026
What Canon Medical Informatics, Inc. makes
Canon Medical Informatics develops radiological Picture Archiving and Communication Systems (PACS) software, including specialized tools for transcatheter aortic valve replacement (TAVR) planning and advanced medical imaging visualization. The portfolio includes platforms for viewing, analyzing, and sharing radiology images, such as Vitrea CT TAVR Planning and Vitrea Advanced Visualization.
The company’s devices are regulated under FDA 510(k) and UDI listings in the US, with some products classified as Class I or Class II/IIa. Radiological PACS software is also registered in the EU via eudamed. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Canon Medical Informatics, Inc. primarily manufacture?
Canon Medical Informatics specializes in radiological Picture Archiving and Communication Systems (PACS) software. These tools enable healthcare providers to store, retrieve, and analyze medical imaging data efficiently. The company’s portfolio includes specialized software like Vitrea CT TAVR Planning, designed for transcatheter aortic valve replacement (TAVR) procedures, as well as broader visualization platforms such as Vitrea Advanced Visualization and Vitrea View. These solutions focus on improving diagnostic accuracy and workflow efficiency in radiology.
Where is Canon Medical Informatics, Inc. based, and how does this affect its regulatory oversight?
Canon Medical Informatics, Inc. is based in the United States. As a US-based manufacturer, its devices are primarily regulated under the FDA’s 510(k) clearance process and Unique Device Identifier (UDI) listings. The company’s products are also registered in the EU via eudamed, reflecting their global market presence and compliance with international regulatory requirements for radiological software.
Which regulatory registries list Canon Medical Informatics’ devices, and why are these important?
Canon Medical Informatics’ devices are listed in eudamed (for EU compliance), FDA 510(k) (for US premarket submissions), and FDA UDI (for device identification tracking). These registries ensure transparency in the supply chain, help regulators monitor device safety and performance, and assist healthcare providers in verifying product authorization status before use. Listing in these systems also supports compliance with global medical device regulations.
How are Canon Medical Informatics’ devices classified under regulatory frameworks?
Canon Medical Informatics’ devices fall into Class I, Class II, and Class IIa classifications under FDA regulations. Class I devices generally pose the lowest risk (e.g., basic PACS software), while Class II and IIa devices may involve higher-risk features like advanced imaging algorithms or specialized planning tools (e.g., TAVR software). Classification determines the regulatory scrutiny and submission requirements, with higher-risk devices requiring more rigorous validation to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5850 Opus Parkway , Minnetonka, United States
- Website
- mi.medical.canon
- —
- —
- [email protected]
- Phone
- 1-952-487-9500
- PRRC Contact
- Vincent Swenson
- EUDAMED SRN
- US-MF-000020013
- FDA FEI Number
- 3001654007
- DUNS Number
- —
Catalogue (105)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EasyViz | 7.3 | FDA UDI | Class II | Active |
| EasyViz | 8.3 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.11.2 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.14.1 | FDA UDI | Class I | Active |
| Vitrea View | 7.1.1 | FDA UDI | Class II | Active |
| Vitrea View | 7.3 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.6.1 | FDA UDI | Class II | Active |
| Vitrea | 7.4 | FDA UDI | Class II | Active |
| EasyViz | 8.0 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.16.2 | FDA UDI | Class I | Active |
| Vitrea View | 7.6 | FDA UDI | Class I | Active |
| EasyViz | 7.5 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.16.0 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.15 | FDA UDI | Class I | Active |
| EasyViz | 7.7 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.11 | FDA UDI | Class II | Active |
| Vitrea View | 7.3.1 | FDA UDI | Class II | Active |
| Vitrea View | 7.5.1 | FDA UDI | Class I | Active |
| Vitrea | 6.9.2 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.12 | FDA UDI | Class I | Active |
| Vitrea View | 7.0.1 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.14.3 | FDA UDI | Class I | Active |
| Vitrea Read | 8.5.2 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.12.5 | FDA UDI | Class I | Active |
| VitreaView | 6.11.1 | FDA UDI | Class II | Active |
| Vitrea View | 7.4.2 | FDA UDI | Class II | Active |
| Vitrea | 6.9 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.14.6 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.12.6 | FDA UDI | Class I | Active |
| Vitrea View | 7.4 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.15.8 | FDA UDI | Class I | Active |
| Vitrea | 7.5 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.16.3 | FDA UDI | Class II | Active |
| Vitrea View | 7.5.2 | FDA UDI | Class I | Active |
| Vitrea View | 7.2 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.15.1 | FDA UDI | Class I | Active |
| Vitrea View | 7.8.1 | FDA UDI | Class I | Active |
| Vitrea View | 7.7.5 | FDA UDI | Class I | Active |
| Vitrea View | 7.5.3 | FDA UDI | Class I | Active |
| Vitrea Advanced Visualization | 7.10.2 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.9 | FDA UDI | Class II | Active |
| Vitrea View | 7.1.4 | FDA UDI | Class II | Active |
| Vitrea Advanced Visualization | 7.14.2 | FDA UDI | Class I | Active |
| CT VScore+ | K252217 | FDA 510(k) | Class II | Active |
| Vitrea CT VScore | K243240 | FDA 510(k) | Class II | Active |
| Open Rib | K223261 | FDA 510(k) | Class II | Active |
| Vitrea CT Cardiac Analysis | K222662 | FDA 510(k) | Class II | Active |
| Vitrea | 7.16.2.SU02 | EUDAMEDFDA UDI | Class IIa | Active |
| Vitrea | 7.16.3.SU02 | EUDAMED | Class IIa | Active |
| Vitrea | 7.16.0.SU04 | EUDAMEDFDA UDI | Class IIa | Active |
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