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FDA 510(k)

我猜CTA中風

K 號:K251590 · 2025-08-20

決定日期2025-08-20
產品代碼QAS
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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其他以 Methinks Software, S.L 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

相關器械(代碼:QAS)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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