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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 Prioritization Software For Lesions
510(k) Number K222076
Device Name EFAI ChestSuite XR Pleural Effusion Assessment System
Applicant
Ever Fortune.Ai, Co., Ltd.
Rm. D, 8f. # 573, Sec.2 Taiwan Blvd. W. Dist.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.Ai, Co., Ltd.
Rm. D, 8f. # 573, Sec.2 Taiwan Blvd. W. Dist.
Taichung City,  TW 403020
Correspondent Contact Ti-Hao Wang
Regulation Number892.2080
Classification Product Code
QFM  
Date Received07/14/2022
Decision Date 09/08/2022
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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