510(k) Report

Devices descending from K113754

9 later devices reach CFR Quant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+1K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+2K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+2K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+2K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+3K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+3K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+3K192277CardIQ FlowGE Medical Systems SCS20200—
+3K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—