# K112881: Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Nexstim OY
- Decided: May 22, 2012 after 235 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924226 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091457: Nexstim Eximia Navigated Brain Stimulation System, Nexstim OY (2009) Summary page 1.
- K924226: Ojemann Cortical Stimulator, Radionics, Inc. (1993) Summary page 1.

## Recalls of this device
- Mar 14, 2017 · Class II · Z-2320-2017: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

## Indications for use
The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH® provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NEXSPEECH is intended to be verified by direct cortical stimulation. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals.

Source page: https://510kreport.com/device/K112881
Methodology: https://510kreport.com/methodology