SGE — Extracranial Positional System For A Transcranial Magnetic Stimulation System Class II

FDA Device Classification

Classification Details

Product Code
SGE
Device Class
Class II
Regulation Number
882.4560
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251927zeta surgicalZeta Navigation System (ZNS131-US)October 10, 2025