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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced Ejection Fraction Machine Learning-Based Notification Software
510(k) Number K254302
Device Name ECG Analysis Software (AiTiALVSD)
Applicant
Medical AI Co., Ltd.
13th Floor, 38, Yeongdong-Daero 85-Gil
Gangnam-Gu, Seoul,  KR 06180
Applicant Contact Hyeri Choi
Correspondent
Medical AI Co., Ltd.
13th Floor, 38, Yeongdong-Daero 85-Gil
Gangnam-Gu, Seoul,  KR 06180
Correspondent Contact Goodman Suzanne
Classification Product Code
QYE  
Date Received12/31/2025
Decision Date 09/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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