510(k) Report

Devices descending from K153073

11 later devices reach UroNav (Version 2.0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182561UroNav (Version 3.0)Invivo Corporation20182—
+1K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+1K170841BiopSee, Mobile USMedcom GmbH20170—
+1K170250SmartTargetSmarttarget, Ltd.201701
+1K162474ArtemisEigen20163—
+2K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—
+2K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+2K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd.20221—
+2K193403UroNav SystemInvivo Corporation20191—
+3K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—
+3K250800UroNav 4Philips DS North America, LLC20250—