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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 K241923
Device Name EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Applicant
Ever Fortune.Ai, Co., Ltd.
Rm. D, 8f. # 573, Sec.2 Taiwan Blvd. W. Dist.
Taichung City,  TW 403020
Applicant Contact Chang Joseph
Correspondent
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Correspondent Contact Dr. Ti-Hao Wang
Regulation Number892.2080
Classification Product Code
QAS  
Date Received07/01/2024
Decision Date 12/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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