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Nexstim Navigated Brain Therapy (NBT) System 2

by Nexstim Plc 2 variants

510(k) K171902

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171902↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK171902 Date10 Nov 2017ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
OBP
Device Class
Class II
Regulation
21 CFR Part 882.5805
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nexstim Navigated Brain Therapy (NBT) System 2 is a Transcranial Magnetic Stimulator, a device used for non-invasive brain stimulation to modulate neural activity. It employs navigated brain mapping and stimulation techniques to target specific cortical regions with precision, facilitating diagnostic and therapeutic applications in neurology.

The system is designed for use in clinical settings, incorporating MRI-compatible components and software for real-time neuronavigation. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accuracy and safety. Authorised under FDA 510(k) and MDD, it adheres to regulatory standards for transcranial magnetic stimulation, with multiple FEI numbers and registration identifiers confirming its compliance.

Other devices from Nexstim Plc

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of clinical settings is the Nexstim Navigated Brain Therapy (NBT) System 2 intended for use in, and why is this important?

    The Nexstim Navigated Brain Therapy (NBT) System 2 is designed exclusively for clinical settings, such as hospitals or specialized neurology centers. This is critical because the system requires precise neuronavigation, MRI-compatible components, and proper calibration—all of which demand controlled environments with trained personnel to ensure patient safety and accurate stimulation targeting. Its use outside clinical settings could compromise sterility, operational accuracy, or compliance with regulatory standards.

  • Is the Nexstim Navigated Brain Therapy (NBT) System 2 a single-use or reusable device, and what does this mean for maintenance?

    The Nexstim Navigated Brain Therapy (NBT) System 2 is a reusable medical device, meaning it is not intended for single-patient use. This classification implies that the system must undergo regular calibration, maintenance, and cleaning as specified by the manufacturer to ensure continued accuracy, safety, and compliance with regulatory standards. Reusability also requires adherence to infection control protocols to prevent cross-contamination between patients.

  • What regulatory pathways does the Nexstim Navigated Brain Therapy (NBT) System 2 follow, and how does this affect its use?

    The system is authorized under FDA 510(k) clearance and the MDD (Medical Device Directive), confirming it meets U.S. and European regulatory standards for transcranial magnetic stimulators. This means it has undergone rigorous review by the FDA’s Neurology Advisory Committee (NE) and is classified as Class II under the FDA’s device hierarchy. Clinicians should verify local regulatory compliance before use, as these pathways ensure the device’s safety, performance, and intended use—specifically for non-invasive brain stimulation in neurology—are validated.

  • Does the Nexstim Navigated Brain Therapy (NBT) System 2 include MRI-compatible components, and why is this feature significant?

    Yes, the system incorporates MRI-compatible components, which allows for seamless integration with MRI imaging during neuronavigation. This feature is significant because it enables precise localization of cortical regions for stimulation, reducing errors in targeting and improving diagnostic or therapeutic outcomes. MRI compatibility also ensures the device can be used in hybrid clinical workflows where imaging and stimulation are performed in the same session.

  • What should clinicians consider when storing the Nexstim Navigated Brain Therapy (NBT) System 2, given its specifications?

    While the provided data does not specify storage conditions explicitly, as a reusable medical device with MRI-compatible components, clinicians should store it in a clean, controlled environment to protect against dust, moisture, or electromagnetic interference. Since the system relies on precise calibration and software functionality, it should also be kept away from extreme temperatures or direct sunlight. Adherence to the manufacturer’s maintenance guidelines—including software updates and hardware checks—is essential to preserve performance and regulatory compliance.