510(k) Report

Devices descending from K143664

6 later devices reach HeartSee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+2K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+2K192277CardIQ FlowGE Medical Systems SCS20200—
+2K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+3K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+4K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—