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Sign in to claim this brandLMT Medical Systems GmbH
US
Last updated May 24, 2026
What LMT Medical Systems GmbH makes
LMT Medical Systems GmbH manufactures radio-frequency coils for MRI systems, including specialized designs for 1.5T and 3.0T scanners, such as the NBAC and NHAC series for spinal and general imaging. They also produce transport infant incubators, including models like the LMT nomag® IC 1.5 and 3.0, designed for neonatal care.
The company’s products are classified as Class II medical devices and are listed under the FDA’s 510(k) and UDI programs. These devices are regulated under US jurisdiction, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does LMT Medical Systems GmbH manufacture?
LMT Medical Systems GmbH specializes in two primary categories of medical devices: radio-frequency coils for MRI systems and transport infant incubators. Their MRI coils include models like the NBAC and NHAC series, designed for 1.5T and 3.0T scanners, catering to spinal and general imaging needs. Additionally, they produce neonatal care devices such as the LMT nomag® IC 1.5 and 3.0, which are transport incubators for infants.
Where is LMT Medical Systems GmbH based, and under which regulatory jurisdiction do their devices fall?
LMT Medical Systems GmbH is based in the United States. Their devices are regulated under US jurisdiction, specifically as Class II medical devices, which are subject to stricter controls due to their moderate risk. This classification aligns with the FDA’s regulatory framework, ensuring compliance with safety and performance standards for these products.
Which regulatory registries or programs list LMT Medical Systems GmbH’s devices?
LMT Medical Systems GmbH’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identification (UDI) system. The 510(k) process ensures that their devices meet FDA requirements for safety and effectiveness by demonstrating substantial equivalence to legally marketed predicates. The UDI system helps track and trace devices throughout their lifecycle, improving patient safety and regulatory oversight.
How are LMT Medical Systems GmbH’s devices classified under FDA regulations?
LMT Medical Systems GmbH’s devices are classified as Class II under FDA regulations. This classification is determined based on the risk associated with the device. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards, post-market surveillance, or labeling requirements. The specific models, like MRI coils and transport incubators, fall into this category due to their moderate risk profiles.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- lmt-medicalsystems.com
- —
- —
- [email protected]
- Phone
- +49451580980
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 312688686
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NBAC 1.5T SMS, Flex | 0800228 | EUDAMEDFDA UDI | Class II | Active |
| Nhac 3.0t Sms 16 | 0800194 | FDA UDI | Class II | Active |
| NBAC 1.5T SMS, Flex | 0800150 | FDA UDI | Class II | Active |
| LMT nomag® IC 3.0 | 0100025 | FDA UDI | Class II | Active |
| NBAC 3.0T SMS, Flex | 0800144 | EUDAMEDFDA UDI | Class II | Active |
| Nhac 1.5t Ph I 16 | 0800198 | EUDAMEDFDA UDI | Class II | Active |
| NBAC 3.0T GE P, Spine | 0800214 | FDA UDI | Class II | Active |
| LMT nomag® IC 1.5 | 0100015 | FDA UDI | Class II | Active |
| NBAC 1.5T PH I Flex | 0800229 | EUDAMEDFDA UDI | Class II | Active |
| Nhac 3.0t Ph I 16 | 0800203 | FDA UDI | Class II | Active |
| LMT nomag® IC 3.0 | 0100020 | FDA UDI | Class II | Unknown |
| LMT nomag® IC 1.5 | 0100010 | FDA UDI | Class II | Unknown |
| NBAC 1.5T SMS, Spine | 0800218 | EUDAMEDFDA UDI | Class II | Active |
| NBAC 1.5T PH I Spine | 0800221 | EUDAMEDFDA UDI | Class II | Active |
| Nhac 1.5t Ge P 16 | 0800196 | FDA UDI | Class II | Active |
| NBAC 3.0T PH I Spine | 0800222 | FDA UDI | Class II | Active |
| Nhac 3.0t Sms | 0800126 | FDA UDI | Class II | Active |
| NBAC 3.0T GE H, Flex | 0800187 | FDA UDI | Class II | Active |
| NBAC 3.0T SMS, Spine | 0800143 | EUDAMEDFDA UDI | Class II | Active |
| Nhac 3.0t Ge P 16 | 0800216 | FDA UDI | Class II | Active |
| Nhac 3.0t Ge P 16 | 0800213 | FDA UDI | Class II | Active |
| Nhac 1.5t Sms 16 | 0800193 | EUDAMEDFDA UDI | Class II | Active |
| Nhac 16 | K171515 | FDA 510(k) | Class II | Active |
| Neonate Array Coils | K091047 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Lmt Medical Systems Gmbh Lubeck Schleswig-Holstein · DE FEI 3009514037