Identity
- Trade Name
- NBAC 3.0T GE H, Flex FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- No description. FDA UDI
- Model / Reference
- 0800187 FDA UDI
- Description
- No description. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260486610377 FDA UDI
- 510(k) Number
- K091047 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 3.0T GE H, Flex by LMT Medical Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- LMT Medical Systems GmbH
Sources (1)
- FDA UDI 2274ff91-7bf8-4e0a-ac0e-1a9cdf0ac25a 35 fields · synced May 30, 2026