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FDA 510(k)

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

K-Number: K232235 · 2023-10-25

ApplicantThe Magstim Company , Ltd.
Decision Date2023-10-25
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is The Magstim Company , Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K232235. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is The Magstim Company , Ltd.. The 510(k) number is K232235.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2023-10-25, under 510(k) number K232235.

Who is the listed applicant 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?

The FDA 510(k) record lists The Magstim Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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?

The FDA product code 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 is OBP.

Other records listing The Magstim Company , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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