Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro— 510(k) K232235

Substantially Equivalent

The Magstim Company , Ltd.

FDA 510(k) clearance K232235 for Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro, Substantially Equivalent on 2023-10-25. Applicant: The Magstim Company , Ltd..

Clearance details

Applicant: The Magstim Company , Ltd.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2023-07-27
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitland, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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