# K091457: Nexstim Eximia Navigated Brain Stimulation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Nexstim OY
- Decided: Dec 8, 2009 after 204 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112881: Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech (TM) (2012), 0 descendants of its own
- K101887: Confident Surgery Suite 300, Model CSS300 (2011), 0 descendants of its own

## Recalls of this device
- Mar 14, 2017 · Class II · Z-2319-2017: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

## Indications for use
The Nexstim eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

Source page: https://510kreport.com/device/K091457
Methodology: https://510kreport.com/methodology