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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K243881
Device Name HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
Applicant
Bracco Diagnostics, Inc.
510 Carnegie Center
Princeton,  NJ  08540
Applicant Contact Elyssa Murray
Correspondent
Bracco Diagnostics, Inc.
510 Carnegie Center
Princeton,  NJ  08540
Correspondent Contact Elyssa Murray
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/18/2024
Decision Date 03/03/2025
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		 No
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