Magstim®Horizon® 3.0 TMS Therapy System - Horizon® 3.0 with Navigation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232235 FDA 510(k)
- FDA Product Code
- OBP FDA 510(k)
- Models / Variants
- Magstim®Horizon® 3.0 TMS Therapy System FDA 510(k)Horizon® 3.0 System FDA 510(k)Horizon® 3.0 FDA 510(k)Horizon® 3.0 with Navigation FDA 510(k)Horizon® 3.0 with StimGuide Pro FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5805 FDA 510(k)
- Regulation Number
- 882.5805 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Magstim Horizon 3.0 TMS Therapy System is a transcranial magnetic stimulator. It is designed to produce and deliver non-invasive magnetic stimulation.
This device is regulated under FDA 510K clearance. It is categorized as a Class 2 medical device within the neurology specialty.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Horizon 3.0 - Magstim, Horizon 3.0 - Magstim, Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232235 | Class II | Active |
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Manufacturer
- Manufacturer
- The Magstim Company , Ltd.
Sources (1)
- FDA 510(k) K232235 24 fields · synced Oct 6, 2026