FDA 510(k)

PROBEAT-V 质子束治疗系统带 X 射线限制附件

K号: K161163 · 2016-07-13

决定日期2016-07-13

产品代码LHN

咨询委员会RA

决定实质等同

器械摘要

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K161163. 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 PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Hitachi , Ltd.. The 510(k) number is K161163.

When did PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory receive FDA 510(k) clearance?

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory received FDA 510(k) clearance on 2016-07-13, under 510(k) number K161163.

Who is the listed applicant for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

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

What is the FDA product code for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

The FDA product code for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is LHN.

列明Hitachi , Ltd.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。

K201042PROBEAT-CR K191801PROBEAT-CR K172087SANGRAY K163505ARIETTA PRECISION K162902ARIETTA Prologue 诊断超声系统和探头 K162583ALOKA LISENDO 880

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