FDA 510(k)

馬格韋恩特 TMS 阿特拉斯神經導航系統

K 號：K221544 · 2023-03-17

決定日期2023-03-17

產品代碼HAW

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 TMS Atlas Neuro Navigation 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 2023-03-17 under 510(k) number K221544. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MagVenture TMS Atlas Neuro Navigation System?

MagVenture TMS Atlas Neuro Navigation System is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K221544.

When did MagVenture TMS Atlas Neuro Navigation System receive FDA 510(k) clearance?

MagVenture TMS Atlas Neuro Navigation System received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221544.

Who is the listed applicant for MagVenture TMS Atlas Neuro Navigation 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 Atlas Neuro Navigation System?

The FDA product code for MagVenture TMS Atlas Neuro Navigation System is HAW.

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。

K260189馬格韋恩加速經颅磁刺激治療系統（aTMS）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 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：HAW）

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。

K253856Geniant Cranial（導航神經外科定位機器人）Koh Young Technology, Inc.K261932萊克塞爾® Vantage 積極定位系統Elekta Solutions AB K253663Zeta導航系統Zeta Surgical, Inc.K253379Stealth AXiS 頭部臨床應用Medtronic Navigation, Inc.K231897神經對齊軟體Medivis, Inc.K251317SOLOPASS 2.0 系統Intravent Medical Partners

官方來源

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