510(k) Report

Devices descending from K131448

6 later devices reach 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd.20172—
+1K160357TrinityKoelis20161—
+1K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+2K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+2K170521Trinity/3D Prostate SuiteKoelis20170—
+3K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—