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FDA 510(k)

MagVenture TMS Therapy System

K-Number: K251119 · 2025-08-08

ApplicantTonica Elektronik A/S
Decision Date2025-08-08
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture TMS Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K251119. 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 MagVenture TMS Therapy System?

MagVenture TMS Therapy System is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K251119.

When did MagVenture TMS Therapy System receive FDA 510(k) clearance?

MagVenture TMS Therapy System received FDA 510(k) clearance on 2025-08-08, under 510(k) number K251119.

Who is the listed applicant for MagVenture TMS Therapy System?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagVenture TMS Therapy System?

The FDA product code for MagVenture TMS Therapy System is OBP.

Other records listing Tonica Elektronik A/S 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.

K260189MagVenture Accelerated TMS (aTMS) Therapy SystemK251125MagVenture TMS Therapy SystemK252032T65 (9016E061-)K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionK221544MagVenture TMS Atlas Neuro Navigation SystemK193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

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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

View on FDA Database →

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

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