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FDA 510(k)

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

K 號：K212289 · 2022-05-06

申請人Neuronetics, Inc.
決定日期2022-05-06
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

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212289. 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 NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Neuronetics, Inc.. The 510(k) number is K212289.

When did NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar receive FDA 510(k) clearance?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212289.

Who is the listed applicant for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA 510(k) record lists Neuronetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is QCI.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Neuronetics, 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。

K231926神經星先進治療系統（所有先前已獲批准的型號）K222230NeuroStar，NeuroStar TMS治療系統，NeuroStar先進治療系統，NeuroStar先進治療系統用於精神健康K220127神經星TMS治療系統，神經星先進治療系統，神經星，神經星先進治療精神健康K213543神經星TMS治療系統，神經星先進治療系統，神經星，神經星先進治療精神健康K201158NeuroStar先進治療K161519神經星TMS治療系統

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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。

K243459最終經颅磁刺激治療強迫症（M系列）Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742雲TMS Edge 用於OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129雲TMS用於OCDTeleemg, LLCK193006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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