FDA 510(k)

AISight Dx

K 號：K243391 · 2025-06-26

決定日期2025-06-26

產品代碼QKQ

諮詢委員會PA

決定相當於

器材摘要

AISight Dx is the device name listed in this FDA 510(k) record. The listed applicant is PathAI, Inc.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243391. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AISight Dx?

AISight Dx is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is PathAI, Inc.. The 510(k) number is K243391.

When did AISight Dx receive FDA 510(k) clearance?

AISight Dx received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243391.

Who is the listed applicant for AISight Dx?

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

What is the FDA product code for AISight Dx?

The FDA product code for AISight Dx is QKQ.

其他以 PathAI, Inc. 為申請人之記錄

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K212361諾沃

相關器械（代碼：QKQ）

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。

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官方來源

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