510(k) Report

Devices descending from K190925

3 later devices reach HeartFlow FFRct Analysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203329HeartFlow AnalysisHeartFlow, Inc.20212—
+2K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+3K250902HeartFlow AnalysisHeartFlow, Inc.20250—