FDA 510(k)

實時影像閘控系統用於質子束治療系統

K 號：K171049 · 2017-12-26

決定日期2017-12-26

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

Real Time Image Gating System for Proton Beam Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Healthcare. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K171049. 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 Real Time Image Gating System for Proton Beam Therapy Systems?

Real Time Image Gating System for Proton Beam Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Hitachi, Ltd. Healthcare. The 510(k) number is K171049.

When did Real Time Image Gating System for Proton Beam Therapy Systems receive FDA 510(k) clearance?

Real Time Image Gating System for Proton Beam Therapy Systems received FDA 510(k) clearance on 2017-12-26, under 510(k) number K171049.

Who is the listed applicant for Real Time Image Gating System for Proton Beam Therapy Systems?

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

What is the FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems?

The FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems is LHN.

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LHN）

官方來源