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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 K253163
Device Name EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
Applicant
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Correspondent Contact Ti-Hao Wang
Regulation Number892.2080
Classification Product Code
QAS  
Date Received09/26/2025
Decision Date 04/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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