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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
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