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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Acquisition And/Or Optimization Guided By Artificial Intelligence
510(k) Number K242807
Device Name HeartFocus (V.1.1.1)
Applicant
Deski
2 Place De La Bourse
Bordeaux,  FR 33000
Applicant Contact Saray Ugidos Seman
Correspondent
Deski
2 Place De La Bourse
Bordeaux,  FR 33000
Correspondent Contact Saray Ugidos Seman
Classification Product Code
QJU  
Date Received09/17/2024
Decision Date 04/04/2025
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		 Yes
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