SIGNA Artist Evo
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- SIGNA Artist Evo EUDAMEDNA FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- SIGNA Artist Evo EUDAMEDSIGNA Artist Evo System Medical Device, MDR FDA UDI
- Model / Reference
- SIGNA Artist Evo EUDAMEDFDA UDI
- Description
- SIGNA Artist Evo System Medical Device, MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278481382 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00286HS EUDAMED
- 510(k) Number
- K213603 FDA UDI
- FDA Product Code
- LNI FDA UDILNH FDA UDIMOS 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Full-body MRI system, superconducting magnet
SIGNA Artist Evo by GE Healthcare Tianjin Company Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Full-body MRI system, superconducting magnet.
- iTX Extremity 18 Flare Coil set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- MAGNETOM Sola Fit — Siemens Healthcare · Class II
- 8 channel wrist coil — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
- 1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
- Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
- InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213603 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00286HS | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Healthcare Tianjin Company Limited
- EUDAMED SRN
- CN-MF-000001725
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED e81cc973-820f-49a8-8a3e-4c203c7c8715 61 fields · synced Jun 20, 2026
- FDA UDI 4169b478-3f3e-48e0-8751-b602829dc481 34 fields · synced May 29, 2026
- FDA 510(k) K213603 1 fields · synced May 18, 2026