FDA 510(k)

OptimMRI (v2)

K号: K242054 · 2024-08-12

决定日期2024-08-12

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

OptimMRI (v2) is the device name listed in this FDA 510(k) record. The listed applicant is Rebrain, Sas. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K242054. 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 OptimMRI (v2)?

OptimMRI (v2) is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Rebrain, Sas. The 510(k) number is K242054.

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

OptimMRI (v2) received FDA 510(k) clearance on 2024-08-12, under 510(k) number K242054.

Who is the listed applicant for OptimMRI (v2)?

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

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

The FDA product code for OptimMRI (v2) is QIH.

列明Rebrain, Sas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。

K230150OptimMRI

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。