# K261471: Zeta TMS Navigation System

- Pathway: 510(k) (Special)
- Applicant: Zeta Surgical, Inc.
- Decided: Jul 9, 2026 after 66 days
- Product code: QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to DEN070003 (2008). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251927: Zeta Navigation System (ZNS131-US), Zeta Surgical, Inc. (2025) Summary page 5.
- K182768: TMS-Cobot TS MV, Axilum Robotics (2019) Summary page 5.

## 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. In addition, the product is intended for use with the Apollo TMS Therapy System supplied by MAG & More GmbH (Munich, Germany), only with the following magnetic coils: PMD70-aCool.

Source page: https://510kreport.com/device/K261471
Methodology: https://510kreport.com/methodology