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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 K221552
Device Name EFAI ChestSuite XR Pneumothorax Assessment System
Applicant
Ever Fortune AI Co., Ltd.
RM.D, 8F, NO. 573, SEC 2, Taiwan Blvd, West Dist.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune AI Co., Ltd.
RM.D, 8F, 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 Received05/31/2022
Decision Date 11/08/2022
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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