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FDA 510(k)

AI4CMR v2.0

K号: K252084 · 2026-02-11

决定日期2026-02-11
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

AI4CMR v2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Ai4medimaging Medical Solutions S.A.. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K252084. 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 AI4CMR v2.0?

AI4CMR v2.0 is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Ai4medimaging Medical Solutions S.A.. The 510(k) number is K252084.

When did AI4CMR v2.0 receive FDA 510(k) clearance?

AI4CMR v2.0 received FDA 510(k) clearance on 2026-02-11, under 510(k) number K252084.

Who is the listed applicant for AI4CMR v2.0?

The FDA 510(k) record lists Ai4medimaging Medical Solutions S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI4CMR v2.0?

The FDA product code for AI4CMR v2.0 is QIH.

列明Ai4medimaging Medical Solutions 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。

相关器械(代码:QIH)

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。

官方来源

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