FDA 510(k)

大脑WMH

K号: K251527 · 2025-09-25

决定日期2025-09-25

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Brain WMH is the device name listed in this FDA 510(k) record. The listed applicant is Quantib B.V.. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251527. 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 Brain WMH?

Brain WMH is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Quantib B.V.. The 510(k) number is K251527.

When did Brain WMH receive FDA 510(k) clearance?

Brain WMH received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251527.

Who is the listed applicant for Brain WMH?

The FDA 510(k) record lists Quantib B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brain WMH?

The FDA product code for Brain WMH is QIH.

列明Quantib B.V.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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