510(k) Report

Devices descending from K172356

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

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