Zeta TMS Navigation System

Primary DI
00860012056811
Brand
Zeta TMS Navigation System
Company
Zeta Surgical Inc.
Model
ZNS131-US
Device description
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.
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System
SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFFElectromechanical Arm For A Transcranial Magnetic Stimulation SystemNeurology2
SGEExtracranial Positional System For A Transcranial Magnetic Stimulation SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012056811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012056811008600120568118600120568110860012056811

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic neuronavigation/planning systemA mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.

Contacts#

Phone, Email table
PhoneEmail
8572254138hieu.lemau@zetasurgical.com
8572725703jose.amich@zetasurgical.com

Regulatory Flags#

DUNS number
117227085
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012056804Zeta Stylet — SZSS-110 US2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06430063200187Nexstim NBS SystemNexstim OyjQFF2025-04-01
03701354600034Axilum RoboticsAXILUM ROBOTICSQFF2021-10-21
03701354600058Axilum RoboticsAXILUM ROBOTICSQFF2021-10-21
03701354620285Axilum RoboticsAXILUM ROBOTICSQFF2020-01-23
03701354620117Axilum RoboticsAXILUM ROBOTICSQFF2019-05-03
03701354620261Axilum RoboticsAXILUM ROBOTICSQFF2019-05-03
03701354630116Axilum RoboticsAXILUM ROBOTICSQFF2019-05-03