FDA 510(k)

Eclipse治療計劃系統（18.1）

K 號：K242378 · 2024-12-11

決定日期2024-12-11

產品代碼MUJ

諮詢委員會RA

決定相當於

器材摘要

Eclipse Treatment Planning System (18.1) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K242378. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eclipse Treatment Planning System (18.1)?

Eclipse Treatment Planning System (18.1) is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Varian Medical Systems. The 510(k) number is K242378.

When did Eclipse Treatment Planning System (18.1) receive FDA 510(k) clearance?

Eclipse Treatment Planning System (18.1) received FDA 510(k) clearance on 2024-12-11, under 510(k) number K242378.

Who is the listed applicant for Eclipse Treatment Planning System (18.1)?

The FDA 510(k) record lists Varian Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eclipse Treatment Planning System (18.1)?

The FDA product code for Eclipse Treatment Planning System (18.1) is MUJ.

其他以 Varian Medical Systems 為申請人之記錄

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相關器械（代碼：MUJ）

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。

K260750虛擬圓錐（1.0）Varian Medical Systems, Inc.K253050RadOncAIInformai K260207多模態模擬工作空間（MM Sim）（v1.0.0）Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT影像套件 VC10Varian Medical Systems, Inc.

官方來源

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