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NexSpeech analyzer software 2

by Nexstim Oyj

NexSpeech analyzer software 2 is a stereotactic neuronavigation/planning system (FDA Class II) made by Nexstim Oyj, cleared under FDA 510(k) K112881 on 22 May 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 06430063200033), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K112881

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06430063200033 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112881 Date22 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112881 decided 22 May 2012 Active
  • FDA GUDID UDI-DI 06430063200033 listed 21 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2320-2017 FDA Class II initiated 14 Mar 2017

    Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

Timeline

3 dated events

  1. Cleared FDA 510(k) K112881
  2. Listed FDA GUDID 06430063200033
  3. Recall initiated FDA recalls Z-2320-2017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NexSpeech analyzer software
Generic name
Stereotactic neuronavigation/planning system
Model / reference
2
Primary DI / UDI-DI
06430063200033
510(k) Number
FDA product code
GWF, IKN, HAW
GMDN term
Stereotactic neuronavigation/planning system
Device class
Class II
Regulation number
882.1870, 890.1375, 882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: ElectromyographStereotactic neuronavigation/planning systemHand-held deep-tissue electromagnetic stimulator

Cleared under the same submission (K112881)

and 2 more cleared under K112881

Similar devices

Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).

Other devices from Nexstim Oyj

See all devices from Nexstim Oyj →

Properties

  • Prescription use
Other properties (14, all answered No)