FDA 510(k)

XBeam（v2）

K号: K240671 · 2024-12-04

决定日期2024-12-04

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

XBeam (v2) is the device name listed in this FDA 510(k) record. The listed applicant is Xstrahl, Ltd.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K240671. 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 XBeam (v2)?

XBeam (v2) is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Xstrahl, Ltd.. The 510(k) number is K240671.

When did XBeam (v2) receive FDA 510(k) clearance?

XBeam (v2) received FDA 510(k) clearance on 2024-12-04, under 510(k) number K240671.

Who is the listed applicant for XBeam (v2)?

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

What is the FDA product code for XBeam (v2)?

The FDA product code for XBeam (v2) is MUJ.

列明Xstrahl, Ltd.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。

K230611X80 / RADiant / 光电疗法系统（RADiant Aura）K172080光电疗法系统

官方来源

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