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Nexstim Navigated Brain Therapy (NBT) System 2

by Nexstim Plc 2 variants

510(k) K182700

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) K182700↗

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 NumberK182700 Date22 Mar 2019ClearedStatusActive
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  • Withdrawn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 (TMS), a non-invasive device used for neuromodulation of the brain. It delivers focused magnetic pulses to stimulate or inhibit neural activity, aiding in the assessment and treatment of neurological conditions, including those evaluated under the advisory committee for Neurology.

This system is designed for clinical use in settings where precise brain mapping and stimulation are required, such as research laboratories and specialized neurological clinics. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance and MDD authorization, with multiple registration numbers (e.g., 3005205657) and product code OBP. The device operates under Class II regulatory classification and is intended for use by trained professionals in controlled environments.

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