Home / 510(k) Clearances / K251927

510(k) K251927

Zeta Navigation System (ZNS131-US) by Zeta Surgical, Inc. — Product Code SGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
June 23, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracranial Positional System For A Transcranial Magnetic Stimulation System
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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

Other clearances by Zeta Surgical, Inc.

  • K242351 — Zeta Cranial Navigation System (ZNS131-US) (October 4, 2024)
  • K233903 — Zeta Cranial Navigation System (ZNS131-US) (January 10, 2024)
  • K230661 — Zeta Cranial Navigation System (September 8, 2023)