FDA 510(k)

X80 / RADiant / 光电疗法系统（RADiant Aura）

K号: K230611 · 2023-07-13

决定日期2023-07-13

产品代码JAD

咨询委员会RA

决定实质等同

器械摘要

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is the device name listed in this FDA 510(k) record. The listed applicant is Xstrahl, Ltd.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K230611. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Xstrahl, Ltd.. The 510(k) number is K230611.

When did X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) receive FDA 510(k) clearance?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) received FDA 510(k) clearance on 2023-07-13, under 510(k) number K230611.

Who is the listed applicant for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

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 X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

The FDA product code for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is JAD.

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。

K240671XBeam（v2）K172080光电疗法系统

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