Identity
- Trade Name
- Vitrea EUDAMEDVitrea Advanced Visualization FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Vitrea Advanced Visualization EUDAMEDThe Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: • Retrieve image data over the network via DICOM • Display of images in dedicated protocols which are automatically adapted based on exam type • Select images for closer examination from a gallery of 2D or 3D views • Interactively manipulate an image in real-time to visualize anatomy and pathology • Annotate, measure, and record selected views • Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device • Retrieve reports that are archived on a Web server FDA UDI
- Model / Reference
- 7.16.0.SU03 EUDAMEDFDA UDI
- Description
- The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: • Retrieve image data over the network via DICOM • Display of images in dedicated protocols which are automatically adapted based on exam type • Select images for closer examination from a gallery of 2D or 3D views • Interactively manipulate an image in real-time to visualize anatomy and pathology • Annotate, measure, and record selected views • Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device • Retrieve reports that are archived on a Web server FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850025268301 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850025268VitreaAVES EUDAMED
- Direct Marketing DI
- 00850025268301 EUDAMED
- 510(k) Number
- K032748 FDA UDIK052632 FDA UDIK071331 FDA UDIK071362 FDA UDIK121213 FDA UDIK122578 FDA UDIK140395 FDA UDIK141302 FDA UDIK143079 FDA UDIK150104 FDA UDIK151283 FDA UDIK151919 FDA UDIK160150 FDA UDIK161157 FDA UDIK172855 FDA UDIK181247 FDA UDIK182230 FDA UDIK222662 FDA UDIK223261 FDA UDI
- FDA Product Code
- LMD FDA UDILLZ FDA UDIJAK FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.2020 FDA UDI892.2050 FDA UDI892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vitrea by Canon Medical Informatics, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850025268VitreaAVES | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Canon Medical Informatics, Inc.
- EUDAMED SRN
- US-MF-000020013
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED c68bd079-f81b-4f90-b69a-0540e6d5a314 61 fields · synced Jun 9, 2026
- FDA UDI f554e69a-52c9-47ef-94dc-72e2bd16f14d 34 fields · synced May 30, 2026