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uOmniscan
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 88002494Model uOmniscan
Identity
- Trade Name
- uOmniscan EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Medical Image Management And Processing System EUDAMEDFDA UDI
- Model / Reference
- uOmniscan EUDAMEDFDA UDI88002494 EUDAMED
- Description
- Medical Image Management and Processing System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576834358 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683435NT EUDAMED
- Direct Marketing DI
- 06971576834358 EUDAMED
- 510(k) Number
- K243666 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030792 REMOTE CONTROL TABLES - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Poland 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
uOmniscan by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243666 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683435NT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000008501
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED f3c9fe78-969a-48d4-973c-8a83dd50d953 61 fields · synced Oct 7, 2026
- FDA UDI 469f398c-08c8-4646-b0ff-3282cc2527a6 35 fields · synced May 30, 2026
- FDA 510(k) K243666 1 fields · synced May 18, 2026