Identity
- Trade Name
- Digital Expert Access FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- Digital Expert Access EUDAMEDDE MR Remote Scan Modality Connectivity Executable_1.5.6-RS FDA UDI
- Model / Reference
- 5941611 EUDAMEDwith Remote scanning for MR FDA UDI
- Description
- DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS FDA UDI
Identifiers
- Catalog Number
- 5941611 FDA UDI
- Primary DI / UDI-DI
- 00195278707741 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004637C EUDAMED
- Direct Marketing DI
- 00195278707741 EUDAMED
- 510(k) Number
- K232346 FDA UDI
- FDA Product Code
- LLZ FDA UDILNH 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 UDI892.1000 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Digital Expert Access by GE Healthcare — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08406821BUG004637C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 3ee0c382-a907-41aa-8fe3-15261b8717d0 61 fields · synced May 30, 2026
- FDA UDI bb87777e-a4ec-4379-94e9-43a2b8324dc7 35 fields · synced May 30, 2026