Identity
- Trade Name
- eUnity EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- eUnity EUDAMEDeUnity software is a diagnostic medical imaging display workstation. As part of an EMR, Portal or as a stand-alone application, eUnity provides secure access to full-fidelity DICOM images with unprecedented performance using nothing more than a common web-browser (no client software to manage.) Medical professionals can now access medical images across multiple sites and multiple PACS using eUnity as their image viewing platform. FDA UDI
- Model / Reference
- eUnity v.7.7+ EUDAMEDeUnity-1 FDA UDI
- Description
- eUnity software is a diagnostic medical imaging display workstation. As part of an EMR, Portal or as a stand-alone application, eUnity provides secure access to full-fidelity DICOM images with unprecedented performance using nothing more than a common web-browser (no client software to manage.) Medical professionals can now access medical images across multiple sites and multiple PACS using eUnity as their image viewing platform. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628914000017 EUDAMEDFDA UDI
- Basic UDI-DI
- 628914EU-X.x9M EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
eUnity by Mach7 Technologies Canada Inc — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mach7 Technologies Canada Inc
Sources (2)
- FDA UDI f57b5c4f-6143-4352-978a-e0d92ee962a9 33 fields · synced Jul 29, 2026
- EUDAMED 6a80eb30-cc7a-4b9c-83fe-4f369fcee358 61 fields · synced Jul 29, 2026