FDA 510(k)

AI-CVD

K 號：K252029 · 2025-12-19

決定日期2025-12-19

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

AI-CVD is the device name listed in this FDA 510(k) record. The listed applicant is HeartLung Corporation. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252029. 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 AI-CVD?

AI-CVD is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is HeartLung Corporation. The 510(k) number is K252029.

When did AI-CVD receive FDA 510(k) clearance?

AI-CVD received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252029.

Who is the listed applicant for AI-CVD?

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

What is the FDA product code for AI-CVD?

The FDA product code for AI-CVD is QIH.

其他以 HeartLung Corporation 為申請人之記錄

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相關器械（代碼：QIH）

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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