FDA 510(k)

PROBEAT-V 質子束治療系統搭配X光限制配件

K 號：K161163 · 2016-07-13

決定日期2016-07-13

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Hitachi , Ltd. 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。

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

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相關器械（代碼：LHN）

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。

K260597VIRTUE QAProNova Solutions K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 陽子治療系統 v3.0Varian Medical Systems, Inc.K253406S250-FIT 酸子束放射治療設備（S250-FIT）Mevion Medical Systems, Inc.K250986S250-FIT 酸子束放射治療設備（S250-FIT）Mevion Medical Systems, Inc.K243900eMotus 呼吸動態管理系統Empnia, Inc.

官方來源

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