510(k) Report

Devices descending from K180019

8 later devices reach CAAS Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251355X1-FFRSpectrawave, Inc.20250—
+1K232147CAAS WorkstationPie Medical Imaging BV20241—
+1K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+2K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+2K243769QFR (3.0)Qfr Solutions BV20250—
+2K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+3K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+3K221711AccuICASArteryFlow Technology Co., Ltd.20230—