FDA 510(k)

RayStation 11B

K号: K220141 · 2022-04-15

决定日期2022-04-15

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

RayStation 11B is the device name listed in this FDA 510(k) record. The listed applicant is RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K220141. 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 RayStation 11B?

RayStation 11B is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K220141.

When did RayStation 11B receive FDA 510(k) clearance?

RayStation 11B received FDA 510(k) clearance on 2022-04-15, under 510(k) number K220141.

Who is the listed applicant for RayStation 11B?

The FDA 510(k) record lists RaySearch Laboratories AB (PUBL) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RayStation 11B?

The FDA product code for RayStation 11B is MUJ.

列明RaySearch Laboratories AB (PUBL)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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