FDA 510(k)

Eclipse 治疗计划系统 (18.1)

K号: K242378 · 2024-12-11

决定日期2024-12-11

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Varian Medical Systems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。

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