FDA 510(k)

RayStation 12A

K号: K222312 · 2023-03-29

决定日期2023-03-29

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

RayStation 12A 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 2023-03-29 under 510(k) number K222312. 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 12A?

RayStation 12A is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K222312.

When did RayStation 12A receive FDA 510(k) clearance?

RayStation 12A received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222312.

Who is the listed applicant for RayStation 12A?

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 12A?

The FDA product code for RayStation 12A 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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