SGE

Extracranial Positional System For A Transcranial Magnetic Stimulation System

Product code: SGE
Device name: Extracranial Positional System For A Transcranial Magnetic Stimulation System
Device class: Class 2
21 CFR: 21 CFR 882.4560
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification definition

Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-10.

Number	Decision date	Applicant	Device name	Summary
K251927	2025-10-10	Zeta Surgical, Inc.	Zeta Navigation System (ZNS131-US)	PDF

1 summaries are archived here for direct download.

Official FDA classification page: SGE

Classification and pathway per current FDA publications. Data from openFDA (CC0).