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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Vascular Physiologic Simulation Software
510(k) Number K250902
Device Name HeartFlow Analysis
Applicant
Heartflow, Inc.
331 E. Evelyn Ave.
Mountain View,  CA  94041
Applicant Contact Kristen DeJeu
Correspondent
Heartflow, Inc.
331 E. Evelyn Ave.
Mountain View,  CA  94041
Correspondent Contact Kristen DeJeu
Regulation Number870.1415
Classification Product Code
PJA  
Subsequent Product Codes
LLZ   QIH  
Date Received03/26/2025
Decision Date 07/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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