510(k) Report

Devices descending from K100793

7 later devices reach Urostation 3D Prostate Suite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis20136—
+2K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd.20172—
+2K160357TrinityKoelis20161—
+2K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+3K170521Trinity/3D Prostate SuiteKoelis20170—
+4K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—