SIGNA Prime Elite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- SIGNA Prime Elite EUDAMEDNA FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- SIGNA Prime Elite EUDAMEDSIGNA Prime Elite System Medical Device FDA UDI
- Model / Reference
- SIGNA Prime Elite EUDAMEDFDA UDI
- Description
- SIGNA Prime Elite System Medical Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278601162 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004837J EUDAMED
- 510(k) Number
- K250379 FDA UDI
- FDA Product Code
- LNI FDA UDILNH 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
- Türkiye 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
Yes
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 Prime Elite 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 | K211980 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08406821BUG004837J | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Tianjin Company Limited
- EUDAMED SRN
- CN-MF-000001725
- FDA Applicant
- Ge Healthcare (Tianjin) Company Limited
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 734d46d0-cfee-4dfd-9e7f-0cc7e0c0bbf7 85 fields · synced Jun 18, 2026
- FDA UDI 988c929a-02c6-4280-a8cc-46e0d117c8c5 34 fields · synced May 30, 2026
- FDA 510(k) K211980 1 fields · synced May 18, 2026