FDA 510(k)

馬格韋恩加速經颅磁刺激治療系統（aTMS）

K 號：K260189 · 2026-05-22

決定日期2026-05-22

產品代碼OBP

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Tonica Elektronik A/S 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251125馬格韋恩 TMS治療系統 K251119馬格韋恩 TMS治療系統 K252032T65 (9016E061-)K230014馬格韻痛療法：MagPro R30、MagPro R30 配備 MagOption、MagPro X100、MagPro X100 配備 MagOption K221544馬格韋恩特 TMS 阿特拉斯神經導航系統 K193006馬格韋恩 TMS治療 – 用於治療強迫症，馬格韋恩 TMS治療系統

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相關器械（代碼：OBP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260396KCS rTMS治療系統（經颅磁刺激器）（MetaStim 100，MetaStim 100A）Fidelity BioPharma Co.K260691BTL-699BTL Industries, Inc.K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS治療系統; Apollo light TMS治療系統Mag & More GmbH K252358Nexstim導向性腦刺激(NBS) 6系統(NBS6)Nexstim Oyj K253098Nexstim導向性腦刺激(NBS) 6系統(NBS6)Nexstim Oyj

官方來源

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