Identity
- Trade Name
- SIGNA Premier EUDAMEDNA FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- SIGNA Premier EUDAMEDSIGNA Premier System Medical Device Assembly, MDR FDA UDI
- Model / Reference
- SIGNA Premier EUDAMEDFDA UDI
- Description
- SIGNA Premier System Medical Device Assembly, MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278010797 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00092HB EUDAMED
- 510(k) Number
- K193282 FDA UDI
- FDA Product Code
- MOS FDA UDILNH FDA UDILNI FDA UDI
- EMDN Code
- Z11050105 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SIGNA Premier by GE Medical Systems, LLC — 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 | K183231 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171128 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00092HB | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems LLC
- EUDAMED SRN
- US-MF-000001632
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 1a02c4f8-19b3-47a1-9993-aa4d18509553 61 fields · synced Jul 21, 2026
- FDA UDI 332dd2de-774f-4fc4-b60d-ce7b39ab6ecc 34 fields · synced May 30, 2026
- FDA 510(k) K183231 1 fields · synced May 18, 2026