510(k) Report

Devices descending from K182035

4 later devices reach FFRct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190925HeartFlow FFRct AnalysisHeartFlow, Inc.20193—
+2K203329HeartFlow AnalysisHeartFlow, Inc.20212—
+3K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—