510(k) Report

Devices descending from K081093

31 later devices reach 3-D Imaging Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+1K222683Fibroid Mapping Reviewer Application (FMRA)Nesa Medtech Private Limited20230—
+1K162474ArtemisEigen20163—
+1K153166Fusion BxFocal Healtcare, Inc.20161—
+1K153073UroNav (Version 2.0)Invivo Corporation201511—
+1K122329BiojetJet Soft Srl20120—
+1K100784UC-Care Navigo SytemUC-CARE, Ltd.20113—
+1K100793Urostation 3D Prostate SuiteKoelis20107—
+1K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd.20221—
+2K182561UroNav (Version 3.0)Invivo Corporation20182—
+2K181290Fusion Bx 2.0Focal Healthcare, Inc.20180—
+2K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+2K170841BiopSee, Mobile USMedcom GmbH20170—
+2K170250SmartTargetSmarttarget, Ltd.201701
+2K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd.20172—
+2K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis20136—
+2K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—
+3K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—
+3K193403UroNav SystemInvivo Corporation20191—
+3K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K160357TrinityKoelis20161—
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K250800UroNav 4Philips DS North America, LLC20250—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—