← Back to catalogue
88001297
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 88001297Model uOmnispace.MR
Identity
- Trade Name
- uOmnispace FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- Medical Image Post-processing Software FDA UDI
- Model / Reference
- uOmnispace.MR EUDAMEDFDA UDI88001297 EUDAMED
- Description
- Medical Image Post-processing Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576834259 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683425NQ EUDAMED
- 510(k) Number
- K233186 FDA UDI
- FDA Product Code
- QIH FDA UDI
- EMDN Code
- Z11050192 MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- MRI system application 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
- 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
Yes
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
88001297 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
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 | K233186 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K253077 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683425NQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 a84c8325-e95d-4fa8-9b04-c37c9045737e 61 fields · synced Oct 6, 2026
- FDA UDI a53ad32e-6042-4f47-b69a-8a0aff13ca0c 35 fields · synced May 30, 2026
- FDA 510(k) K233186 1 fields · synced May 18, 2026