Identity
- Trade Name
- NBAC 3.0T SMS Spine EUDAMEDNBAC 3.0T SMS, Spine FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Magnetic Resonance (MR) Radiofrequency Volumetric Coils EUDAMEDNo description. FDA UDI
- Model / Reference
- 0800219 EUDAMEDFDA UDI0800143 FDA UDI
- Description
- No description. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260486610636 EUDAMEDFDA UDI04260486610209 FDA UDI
- Basic UDI-DI
- 426048661CoilsPK EUDAMED
- 510(k) Number
- K091047 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn 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
No
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
MR Conditional FDA UDI
NBAC 3.0T SMS, Spine by LMT Medical Systems GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K091047 also covers:
- NBAC 1.5T PH I Flex — LMT Medical Systems GmbH
- NBAC 1.5T PH I Spine — LMT Medical Systems GmbH
- NBAC 1.5T SMS, Flex — LMT Medical Systems GmbH
- NBAC 1.5T SMS, Flex — LMT Medical Systems GmbH
- NBAC 1.5T SMS, Spine — LMT Medical Systems GmbH
- NBAC 3.0T GE H, Flex — LMT Medical Systems GmbH
- NBAC 3.0T GE P, Spine — LMT Medical Systems GmbH
- NBAC 3.0T PH I Spine — LMT Medical Systems GmbH
- NBAC 3.0T SMS, Flex — LMT Medical Systems GmbH
- NHAC 3.0T SMS — LMT Medical Systems GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- LMT Medical Systems GmbH
Sources (3)
- FDA UDI 17f92da1-2121-4d12-b428-e95f655cecbc 36 fields · synced Jul 30, 2026
- FDA UDI b45a90bc-51a9-44ff-a9f4-0f7d8d1337c7 35 fields · synced May 29, 2026
- EUDAMED c05f222f-36bf-46d2-ad3d-2479d49dc5e8 61 fields · synced Jul 30, 2026