# K191422: Neural Navigator

- Pathway: 510(k) (Traditional)
- Applicant: Soterix Medical, Inc.
- Decided: Apr 6, 2020 after 313 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: 6 generations back to DEN070003 (2008). 6 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K223577: Localite TMS Navigator TS (2023), 2 descendants of its own
- K251927: Zeta Navigation System (ZNS131-US) (2025), 1 descendant of its own
- K210109: visor2 system (2022), 1 descendant of its own
- K201035: ETHICON Linx Esophagus Sizing Tool (2020), 1 descendant of its own
- K261228: QuickVision Ultimate rTMS (2026), 0 descendants of its own

## Indications for use
The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.

Source page: https://510kreport.com/device/K191422
Methodology: https://510kreport.com/methodology