Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Nexstim Oyj
Identifiers
- 510(k) Number
- K253098 FDA 510(k)
- FDA Product Code
- OBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5805 FDA 510(k)
- Regulation Number
- 882.5805 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is a Transcranial Magnetic Stimulator, designed for non-invasive brain stimulation and mapping. It combines magnetic stimulation with advanced neuro-navigation to facilitate precise cortical mapping and functional assessment of brain regions, aiding in clinical and research applications within neurology.
The system is supplied as a reusable medical device, intended for use in clinical settings with appropriate training. It operates under FDA 510(k) clearance and adheres to Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The NBS6 includes multiple FEI numbers, indicating its classification as a Class II device, and is intended for use in MRI-safe environments where applicable. Storage and handling follow standard sterile or non-sterile medical device protocols as specified by the manufacturer.
Frequently asked questions
What clinical applications is the Nexstim Navigated Brain Stimulation (NBS) 6 System primarily used for?
The NBS6 is designed for non-invasive brain stimulation and mapping, combining magnetic stimulation with neuro-navigation to facilitate precise cortical mapping and functional assessment of brain regions. This makes it particularly useful in clinical and research settings within neurology, such as preoperative planning, epilepsy evaluation, or studying brain connectivity.
Is the Nexstim NBS6 System reusable, or is it intended for single-use?
The NBS6 is explicitly described as a reusable medical device, intended for use in clinical settings with appropriate training. It follows standard protocols for storage and handling, which may include cleaning and maintenance procedures to ensure safe, repeated use.
What regulatory pathways has the Nexstim NBS6 System undergone, and what does this mean for its use?
The NBS6 has received FDA 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed device. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards in Europe. This means it is authorized for use in the U.S. and EU markets under these respective regulatory frameworks, ensuring it meets safety and performance requirements.
Can the Nexstim NBS6 System be used in MRI-safe environments?
Yes, the NBS6 is explicitly noted as intended for use in MRI-safe environments where applicable. This means it has been designed and tested to minimize interference with MRI systems, making it suitable for facilities where both devices are used.
How is the NBS6 System supplied, and what should be considered for storage?
The NBS6 is supplied as a reusable system, meaning it is not single-use. Storage and handling follow standard protocols for reusable medical devices, which may include cleaning, disinfection, and proper storage conditions to maintain sterility or non-sterility as specified by the manufacturer. Since it is reusable, adherence to these protocols is critical to ensure safety and functionality over repeated uses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253098 | Class II | Active |
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Manufacturer
- Manufacturer
- Nexstim Oyj
Sources (2)
- FDA 510(k) K253098 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026