Identity
- Trade Name
- NBAC 1.5T PH I Flex EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Magnetic Resonance (MR) Radiofrequency Volumetric Coils EUDAMEDNo description. FDA UDI
- Model / Reference
- 0800229 EUDAMEDFDA UDI
- Description
- No description. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260486610957 EUDAMEDFDA 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
- Germany 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
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
Category: MRI system coil, radio-frequency
NBAC 1.5T PH I Flex by LMT Medical Systems GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K091047 also covers:
- 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 (2)
- FDA UDI d9aead2b-649e-4c02-99e2-9be76e25dbf8 35 fields · synced Jun 18, 2026
- EUDAMED 4f30c3ac-3e0b-429a-a913-4a1b50f0d65d 61 fields · synced Jun 18, 2026