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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, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST DIST.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.AI Co., Ltd.
RM. D, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST 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
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