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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K212624
Device Name EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Applicant
Ever Fortune. AI Co., Ltd.
Rm. D, 8F , NO. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung,  TW 403020
Applicant Contact Chen Ming-Fong
Correspondent
Ever Fortune. AI Co., Ltd.
Rm. D, 8F , NO. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung,  TW 403020
Correspondent Contact Chen Ming-Fong
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/18/2021
Decision Date 04/04/2022
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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