DeviceClearance

Product code SGE— Neurology

Zeta Navigation System (ZNS131-US)

Classification name
Extracranial Positional System For A Transcranial Magnetic Stimulation System
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SGE under 21 CFR 882.4560, via openFDA

Market context for product code SGE

FDA has cleared 1 device under product code SGE, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGE

Recent clearances under product code SGE

Data sourced from openFDA. This site is unofficial and independent of the FDA.