FDA 510(k)

最終經颅磁刺激治療強迫症（M系列）

K 號：K243459 · 2025-04-17

決定日期2025-04-17

產品代碼QCI

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

Ultimate rTMS for OCD (M-series) is the device name listed in this FDA 510(k) record. The listed applicant is Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K243459. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ultimate rTMS for OCD (M-series)?

Ultimate rTMS for OCD (M-series) is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Brain Ultimate, Inc.. The 510(k) number is K243459.

When did Ultimate rTMS for OCD (M-series) receive FDA 510(k) clearance?

Ultimate rTMS for OCD (M-series) received FDA 510(k) clearance on 2025-04-17, under 510(k) number K243459.

Who is the listed applicant for Ultimate rTMS for OCD (M-series)?

FDA 510(k) 記錄將 Brain Ultimate, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ultimate rTMS for OCD (M-series)?

The FDA product code for Ultimate rTMS for OCD (M-series) is QCI.

其他以 Brain Ultimate, Inc. 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。

K261228QuickVision Ultimate rTMS K243460最終經颅磁刺激器 K230735最終rTMS；盈池rTMS

相關器械（代碼：QCI）

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。

K230657BTL-99-OCBTL Industries, Inc.K233742雲TMS Edge 用於OCDTeleemg, LLC K231350OCD MT Cap (85-00397-000)Neuronetics K221129雲TMS用於OCDTeleemg, LLC K212289神經星先進治療法用於OCD的輔助治療，神經星先進治療系統，神經星TMS治療系統，神經星先進治療法用於精神健康，神經星Neuronetics, Inc.K193006馬格韋恩 TMS治療 – 用於治療強迫症，馬格韋恩 TMS治療系統Tonica Elektronik A/S

官方來源

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