Identity
- Trade Name
- SIGNA Pioneer EUDAMEDNA FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- SIGNA Pioneer EUDAMEDSIGNA Pioneer System Medical Device Assembly - MDR FDA UDI
- Model / Reference
- SIGNA Pioneer EUDAMEDFDA UDI
- Description
- SIGNA Pioneer System Medical Device Assembly - MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278005502 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00093HD EUDAMED
- 510(k) Number
- K160621 FDA UDI
- FDA Product Code
- LNH 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 Pioneer by GE Medical Systems, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00093HD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 362f7e38-aa0f-40c6-9ba8-4d11f5a4ae62 61 fields · synced Jul 9, 2026
- FDA UDI 8252eb14-0e0c-4f30-8407-419d7c8d01e0 34 fields · synced May 25, 2026