# K223577: Localite TMS Navigator TS

- Pathway: 510(k) (Traditional)
- Applicant: Localite GmbH
- Decided: Apr 17, 2023 after 138 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070003 (2008). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191422: Neural Navigator, Soterix Medical, Inc. (2020) Summary page 4.
- K171902: Nexstim Navigated Brain Therapy (NBT) System 2, Nexstim Plc (2017) Summary page 4.

## Most influential descendants
- K251927: Zeta Navigation System (ZNS131-US) (2025), 1 descendant of its own
- K261471: Zeta TMS Navigation System (2026), 0 descendants of its own

## Indications for use
The TMS Navigator TS helps users to plan, implement and document treatment involving TMS of the brain. The system provides planning and navigation functions using anatomical MR data. Regions of the brain to be stimulated can be determined on the basis of anatomy, functional areas or by entering previously calculated coordinates from brain atlases. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R20 and R30 stimulators, the R30 TMS stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: C-100, C-B60, Cool-B65, Cool-B70, Cool D-B80, MC-125, MC-B70, MCF-75, MCF-125, MCF-B65 and MMC-140-II.

Source page: https://510kreport.com/device/K223577
Methodology: https://510kreport.com/methodology