Identity
- Trade Name
- Vitrea Enterprise Viewer FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. FDA UDI
- Model / Reference
- 7.0 FDA UDI
- Description
- VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853866003223 FDA UDI
- 510(k) Number
- K150738 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Radiological PACS software
Vitrea Enterprise Viewer by Canon Medical Informatics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological PACS software.
- AVIEW — CORELINE SOFT CO., LTD. · Class II
- ThinkingNet — THINKING SYSTEMS CORP. · Class II
- IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
- EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
- QuantX — Qlarity Imaging · Class II
- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Canon Medical Informatics, Inc.
Sources (1)
- FDA UDI b5ac5217-5a82-44bd-9be6-9b746812de4b 34 fields · synced Jun 9, 2026