FDA 510(k)

AI-Rad Companion脑部MRI

K号: K232305 · 2023-10-23

决定日期2023-10-23

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

AI-Rad Companion Brain MR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K232305. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AI-Rad Companion Brain MR?

AI-Rad Companion Brain MR is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Siemens Medical Solutions U.S.A.. The 510(k) number is K232305.

When did AI-Rad Companion Brain MR receive FDA 510(k) clearance?

AI-Rad Companion Brain MR received FDA 510(k) clearance on 2023-10-23, under 510(k) number K232305.

Who is the listed applicant for AI-Rad Companion Brain MR?

The FDA 510(k) record lists Siemens Medical Solutions U.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-Rad Companion Brain MR?

The FDA product code for AI-Rad Companion Brain MR is QIH.

列明Siemens Medical Solutions U.S.A.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。

K232899AI-Rad Companion器官实时放疗 K222360AI-Rad Companion（心血管）

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。