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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K240291
Device Name EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Applicant
Ever Fortune.AI, Co., Ltd.
Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd. West Dist.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.AI, Co., Ltd.
Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd. West Dist.
Taichung City,  TW 403020
Correspondent Contact Ti-Hao Wang
Regulation Number892.2080
Classification Product Code
QAS  
Date Received02/01/2024
Decision Date 04/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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