Identity
- Trade Name
- EasyViz FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. FDA UDI
- Model / Reference
- 7.7 FDA UDI
- Description
- EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628105001779 FDA UDI
- FDA Product Code
- LMD FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2020 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
EasyViz by Canon Medical Informatics A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Canon Medical Informatics A/S
Sources (2)
- FDA UDI 727c7645-d3e5-4919-b174-d344ca75fe51 33 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026