FDA 510(k)

腦部白質異常

K 號：K251527 · 2025-09-25

決定日期2025-09-25

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Quantib B.V. 為申請人之記錄

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相關器械（代碼：QIH）

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官方來源

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