FDA 510(k)

ProBeam 360 Proton Therapy System v3.0

K号: K252815 · 2026-04-23

决定日期2026-04-23

产品代码LHN

咨询委员会RA

决定实质等同

器械摘要

ProBeam 360 Proton Therapy System v3.0 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 2026-04-23 under 510(k) number K252815. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ProBeam 360 Proton Therapy System v3.0?

ProBeam 360 Proton Therapy System v3.0 is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K252815.

When did ProBeam 360 Proton Therapy System v3.0 receive FDA 510(k) clearance?

ProBeam 360 Proton Therapy System v3.0 received FDA 510(k) clearance on 2026-04-23, under 510(k) number K252815.

Who is the listed applicant for ProBeam 360 Proton Therapy System v3.0?

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。

What is the FDA product code for ProBeam 360 Proton Therapy System v3.0?

The FDA product code for ProBeam 360 Proton Therapy System v3.0 is LHN.

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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