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FDA 510(k)

簡易病例分類

K 號:K253265 · 2025-11-06

決定日期2025-11-06
產品代碼QAS
諮詢委員會RA
決定相當於

器材摘要

BriefCase-Triage is the device name listed in this FDA 510(k) record. The listed applicant is Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K253265. 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 BriefCase-Triage?

BriefCase-Triage is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Aidoc Medical , Ltd.. The 510(k) number is K253265.

When did BriefCase-Triage receive FDA 510(k) clearance?

BriefCase-Triage received FDA 510(k) clearance on 2025-11-06, under 510(k) number K253265.

Who is the listed applicant for BriefCase-Triage?

The FDA 510(k) record lists Aidoc Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BriefCase-Triage?

The FDA product code for BriefCase-Triage is QAS.

相關臨床試驗

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其他以 Aidoc Medical , Ltd. 為申請人之記錄

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相關器械(代碼:QAS)

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官方來源

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