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AIR Anterior Array
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 5746694Model 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL 510(k) K172695
Identity
- Trade Name
- AIR Anterior Array EUDAMEDNA FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL EUDAMED
- Model / Reference
- 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL EUDAMED5746694 EUDAMEDAIR Anterior Array 5746694 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682138611 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00310GW EUDAMED
- 510(k) Number
- K172695 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I 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
Category: MRI system coil, radio-frequency
AIR Anterior Array by GE Healthcare Coils — Class I — 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
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 | K172695 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00310GW | Class I | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Coils
- EUDAMED SRN
- US-MF-000001664
- FDA Applicant
- Ge Healthcare Coils (Usa Instruments, Inc.)
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED f06ecaa6-7e97-45d3-a2c7-ce8bd2912607 85 fields · synced Jun 19, 2026
- FDA UDI e215da12-bfa7-4791-be21-ef4fa8193cf5 33 fields · synced May 30, 2026
- FDA 510(k) K172695 1 fields · synced May 18, 2026