# K251927: Zeta Navigation System (ZNS131-US)

- Pathway: 510(k) (Special)
- Applicant: Zeta Surgical, Inc.
- Decided: Oct 10, 2025 after 109 days
- Product code: SGE (Extracranial Positional System For A Transcranial Magnetic Stimulation System)
- 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: 8 generations back to DEN070003 (2008). 8 ancestors in all.
1 later device descends 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)
- K223577: Localite TMS Navigator TS, Localite GmbH (2023) Summary page 5.

## Most influential descendants
- K261471: Zeta TMS Navigation System (2026), 0 descendants of its own

## Indications for use
The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO.

Source page: https://510kreport.com/device/K251927
Methodology: https://510kreport.com/methodology