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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 K260780
Device Name HeartFocus
Applicant
Deski
2 Pl. De La Bourse
Bordeaux,  FR 33000
Applicant Contact Kelly Porfirio
Correspondent
Deski
2 Pl. De La Bourse
Bordeaux,  FR 33000
Correspondent Contact Kelly Porfirio
Classification Product Code
QJU  
Date Received03/10/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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