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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 K231025
Device Name EFAI NeuroSuite CT ICH Assessment System
Applicant
Ever Fortune.AI Co., Ltd.
8F., No. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.AI Co., Ltd.
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 Received04/11/2023
Decision Date 10/04/2023
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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