Zeta TMS Navigation System

The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with…

Registry build 21.09.26

The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with accurate positioning of the coils of TMS treatment systems relative to patient anatomy by displaying the position of a navigated TMS coil relative to 3D neuroimaging scans. The system provides navigation in three planes (axial, sagittal, and coronal) and enables the selection of target anatomical points. The underlying RealTrack algorithm allows for real-time tracking of head movement using only the patient’s native anatomical features, eliminating the need for rigid head immobilization, body-mounted frames, or facial fiducials.

1manufacturer
1catalogue number
1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code SGE
Manufacturer City Province Registered as Device types
Shenzhen Yingchi Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3

Record

Regulatory record for Zeta TMS Navigation System
Listed by Zeta Surgical Inc., United States
FDA product code SGE
Device type Extracranial Positional System For A Transcranial Magnetic Stimulation System
Device class Class 2
Regulation 21 CFR 882.4560
Establishment Manufacturer
Record published 2026-05-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Zeta TMS Navigation System
Catalogue number Size Status
ZNS131-US In distribution

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K251927 2025-10-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer