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OmegaAI Image Viewer
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref OAIIV1510(k) K222476
by RamSoft Inc.
Identity
- Trade Name
- RamSoft FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- OmegaAI Image Viewer EUDAMEDFDA UDI
- Model / Reference
- OAIIV1 EUDAMED1.0 FDA UDI
- Description
- OmegaAI Image Viewer FDA UDI
Identifiers
- Catalog Number
- OAIIV1 FDA UDI
- Primary DI / UDI-DI
- B359OAIIV11 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B359OAIIV11 EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030582,Z110703 EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
OmegaAI Image Viewer by Ramsoft Inc — Class I — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222476 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-B359OAIIV11 | Class I | Active |
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Manufacturer
- Manufacturer
- RamSoft Inc.
- EUDAMED SRN
- CA-MF-000038450
- FDA Applicant
- Ramsoft, Inc.
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED 3b976853-7202-4d77-ae4b-9f9779b94d4e 85 fields · synced Jun 19, 2026
- FDA UDI 904956f3-ca43-4dbf-b1d9-afed8f1c8443 34 fields · synced May 30, 2026
- FDA 510(k) K222476 1 fields · synced May 18, 2026