Identity
- Trade Name
- SIGNA Voyager EUDAMEDNA FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- SIGNA Voyager EUDAMEDKizuna System Medical Device Assembly-MDR FDA UDI
- Model / Reference
- SIGNA Voyager EUDAMEDFDA UDI
- Description
- Kizuna System Medical Device Assembly-MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278124609 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00101GK EUDAMED
- FDA Product Code
- LNH 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 Voyager by GE Healthcare Tianjin Company Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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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 | K161567 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00101GK | 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 22f82c29-740b-4575-ba50-95c48a3aa04b 61 fields · synced Oct 7, 2026
- FDA UDI d4eceb58-c2cd-4d9f-95d9-2b2f876ea174 33 fields · synced May 30, 2026
- FDA 510(k) K161567 1 fields · synced May 18, 2026