FDA 510(k)

EFAI 心臟套房 CTA 急性主动脉综合症評估系統

K 號：K240291 · 2024-04-08

決定日期2024-04-08

產品代碼QAS

諮詢委員會RA

決定相當於

器材摘要

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2024-04-08 under 510(k) number K240291. 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 EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2024-04-08. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K240291.

When did EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM receive FDA 510(k) clearance?

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM received FDA 510(k) clearance on 2024-04-08, under 510(k) number K240291.

Who is the listed applicant for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM?

The FDA product code for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is QAS.

其他以 Ever Fortune.Ai, Co., Ltd. 為申請人之記錄

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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。

K260906a2z-Abdo-分類評估A2z Radiology Ai, Inc.K261085快速血管阻塞（快速VO）iSchemaview K260729血管輔助阻斷分類（VAOT）（v1.0）GuideAI Health K261317簡易病例分類Aidoc Medical , Ltd.K253163EFAI ERSUITE CT 腹膜炎評估系統 (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.

官方來源

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