FDA 510(k)

Halcyon, Ethos Radiotherapy System (5.0)

K号: K252977 · 2026-01-21

决定日期2026-01-21

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Halcyon, Ethos Radiotherapy System (5.0) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K252977. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是Halcyon, Ethos放射治疗系统（5.0）？

Halcyon, Ethos Radiotherapy System (5.0) is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K252977.

Halcyon, Ethos放射治疗系统（5.0）何时获得FDA 510(k)批准？

Halcyon, Ethos Radiotherapy System (5.0) received FDA 510(k) clearance on 2026-01-21, under 510(k) number K252977.

谁是Halcyon，Ethos放射治疗系统（5.0）的列名申请人？

FDA 510(k)记录中列出Varian Medical Systems, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

什么是Halcyon, Ethos放射治疗系统（5.0）的FDA产品代码？

Halcyon, Ethos 放疗系统（5.0）的FDA产品代码是IYE。

列明Varian Medical Systems, Inc.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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