Identity
- Trade Name
- SIGNA Artist EUDAMEDNA FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- SIGNA Artist EUDAMEDSIGNA Artist Upgrade Medical Device- MDR FDA UDI
- Model / Reference
- SIGNA Artist EUDAMEDFDA UDI
- Description
- SIGNA Artist Upgrade Medical Device- MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278126443 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00098HP EUDAMED
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SIGNA Artist by GE Healthcare Tianjin Company Limited — 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 | K202238 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00098HP | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Tianjin Company Limited
- EUDAMED SRN
- CN-MF-000001725
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED f1a3e1ca-9337-48cb-92df-f28a52480b05 61 fields · synced Oct 6, 2026
- FDA UDI db09f9e5-3222-4e3d-a809-d34bcdd8fed5 34 fields · synced May 30, 2026
- FDA 510(k) K202238 1 fields · synced May 18, 2026