510(k) Report

Devices descending from K153101

4 later devices reach BladderScan Prime System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172356BladderScan Prime PLUS SystemVerathon Incorporated201731
+2K231677EdgeFlow UH10Edgecare, Inc.20241—
+2K200980Auto 3D Bladder Volume ToolButterfly Network, Inc.20200—
+3K252237EdgeFlow UW20Edgecare, Inc.20260—