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FDA 510(k)

MagVenture Accelerated TMS (aTMS) Therapy System

K-Number: K260189 · 2026-05-22

ApplicantTonica Elektronik A/S
Decision Date2026-05-22
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture Accelerated TMS (aTMS) 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 2026-05-22 under 510(k) number K260189. 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 Accelerated TMS (aTMS) Therapy System?

MagVenture Accelerated TMS (aTMS) Therapy System is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K260189.

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

MagVenture Accelerated TMS (aTMS) Therapy System received FDA 510(k) clearance on 2026-05-22, under 510(k) number K260189.

Who is the listed applicant for MagVenture Accelerated TMS (aTMS) 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 Accelerated TMS (aTMS) Therapy System?

The FDA product code for MagVenture Accelerated TMS (aTMS) Therapy System is OBP.

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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 GmbHK253098Nexstim 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.K251391BrainsWay Deep TMS SystemBrainsway , Ltd.

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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