# NexSpeech analyzer software 2

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/nexspeech-analyzer-software-2>
- Manufacturer: [Nexstim Oyj](https://devicerts.com/manufacturers/nexstim-oyj) (Finland)
- Device class: Class II (US FDA)
- FDA product code: GWF, IKN, HAW
- GMDN: Stereotactic neuronavigation/planning system (56641)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 06430063200033 · listed 2016-09-21 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K112881 · decision 2012-05-22 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2320-2017 · Class II · ongoing · initiated 2017-03-14: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

## Identity

- Trade name: NexSpeech analyzer software [FDA GUDID (AccessGUDID)]
- Generic name: Stereotactic neuronavigation/planning system [FDA GUDID (AccessGUDID)]
- Model / reference: 2 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 06430063200033 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K112881 [FDA GUDID (AccessGUDID)]
- FDA product code: GWF [FDA GUDID (AccessGUDID)]; IKN [FDA GUDID (AccessGUDID)]; HAW [FDA GUDID (AccessGUDID)]
- GMDN term: Stereotactic neuronavigation/planning system (56641) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.1870 [FDA GUDID (AccessGUDID)]; 890.1375 [FDA GUDID (AccessGUDID)]; 882.4560 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: NexSpeech analyzer software 2, Nexstim Oyj. deviCERTS medical device catalogue. https://devicerts.com/devices/nexspeech-analyzer-software-2 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/nexspeech-analyzer-software-2.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/nexspeech-analyzer-software-2
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.