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FDA 510(k)

NeuroStar 高级治疗用于强迫症的辅助治疗，NeuroStar 高级治疗系统，NeuroStar TMS 治疗系统，NeuroStar 高级治疗用于心理健康，NeuroStar

K号: K212289 · 2022-05-06

申请人Neuronetics, Inc.
决定日期2022-05-06
产品代码QCI
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Neuronetics, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K231926NeuroStar 高级治疗系统（所有先前已批准的型号）K222230NeuroStar，NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar 高级治疗系统用于心理健康K220127NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar，NeuroStar 高级治疗用于心理健康K213543NeuroStar TMS 治疗系统，NeuroStar 高级治疗系统，NeuroStar，NeuroStar 高级治疗用于心理健康K201158NeuroStar 高级治疗K161519NeuroStar TMS 治疗系统

查看所有 8 个设备 →

相关器械（代码：QCI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243459终极经颅磁刺激器（OCD）系列（M系列）Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge 用于强迫症Teleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS 用于强迫症Teleemg, LLCK193006MagVenture TMS治疗 - 用于治疗OCD，MagVenture TMS治疗系统Tonica Elektronik A/S

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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