FDA 510(k)

Methinks CTA 中风

K号: K251590 · 2025-08-20

决定日期2025-08-20

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Methinks CTA Stroke is the device name listed in this FDA 510(k) record. The listed applicant is Methinks Software, S.L. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251590. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Methinks CTA Stroke?

Methinks CTA Stroke is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Methinks Software, S.L. The 510(k) number is K251590.

When did Methinks CTA Stroke receive FDA 510(k) clearance?

Methinks CTA Stroke received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251590.

Who is the listed applicant for Methinks CTA Stroke?

The FDA 510(k) record lists Methinks Software, S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Methinks CTA Stroke?

The FDA product code for Methinks CTA Stroke is QAS.

列明Methinks Software, S.L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。

K250685Methinks NCCT 中风

官方来源

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