510(k) Report

Devices descending from K101279

12 later devices reach CORRIDOR4DM V2010 Model: V2010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2608794DMInvia, LLC20260—
+1K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+1K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+1K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+2K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+2K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+2K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+3K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+3K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+4K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+4K192277CardIQ FlowGE Medical Systems SCS20200—
+4K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—