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FDA 510(k)

质子治疗系统 - Proteus 235（Proteus One，Proteus Plus，Proteus TK2）

K号: K152224 · 2016-08-09

申请人Ion Beam Application S.A.
决定日期2016-08-09
产品代码LHN
咨询委员会RA
决定实质等同

器械摘要

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is the device name listed in this FDA 510(k) record. The listed applicant is Ion Beam Application S.A.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K152224. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)?

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Ion Beam Application S.A.. The 510(k) number is K152224.

When did Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) receive FDA 510(k) clearance?

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) received FDA 510(k) clearance on 2016-08-09, under 510(k) number K152224.

Who is the listed applicant for Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)?

The FDA 510(k) record lists Ion Beam Application S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)?

The FDA product code for Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is LHN.

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

相关器械（代码：LHN）

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。

K260597VIRTUE 质量认证ProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT 质子束放射治疗设备 (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT 质子束放射治疗设备 (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus 呼吸运动管理系统Empnia, Inc.

官方来源

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