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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 K242821
Device Name EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Applicant
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Applicant Contact Chang Joseph
Correspondent
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Correspondent Contact Wang Ti-Hao
Regulation Number892.2080
Classification Product Code
QAS  
Date Received09/18/2024
Decision Date 02/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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