510(k) Report

Devices descending from K051673

192 later devices reach Xeleris 2 Processing and Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131233Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB201316—
+1K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa20101341
+1K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd.20091—
+1K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+1K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions2008187
+1K0810933-D Imaging WorkstationEigen, LLC200831—
+1K061587Fullcard AnalysisGE Healthcare20061—
+2K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+2K222683Fibroid Mapping Reviewer Application (FMRA)Nesa Medtech Private Limited20230—
+2K192277CardIQ FlowGE Medical Systems SCS20200—
+2K162474ArtemisEigen20163—
+2K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB201610—
+2K153166Fusion BxFocal Healtcare, Inc.20161—
+2K153073UroNav (Version 2.0)Invivo Corporation201511—
+2K142631Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB201411—
+2K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415—
+2K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377—
+2K130393Mirada RTXMirada Medical, Ltd.201336—
+2K122329BiojetJet Soft Srl20120—
+2K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+2K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions2012161
+2K100784UC-Care Navigo SytemUC-CARE, Ltd.20113—
+2K103710WBR Xpress PetUltraspect, Ltd.20110—
+2K102687Mirada RTMirada Medical, Ltd.201037—
+2K100793Urostation 3D Prostate SuiteKoelis20107—
+2K101228Mirada XDMirada Medical, Ltd.201070—
+2K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd.20221—
+3K220779XDMirada Medical, Ltd.20220—
+3K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+3K202700ART-PlanTherapanacea20215—
+3K200323AutoContourRadformation, Inc.20207—
+3K182561UroNav (Version 3.0)Invivo Corporation20182—
+3K181572Workflow BoxMirada Medical, Ltd.201825—
+3K181290Fusion Bx 2.0Focal Healthcare, Inc.20180—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+3K171681Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB201721
+3K171719Hybrid3DHermes Medical Solutions AB20175—
+3K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+3K170841BiopSee, Mobile USMedcom GmbH20170—
+3K170250SmartTargetSmarttarget, Ltd.201701
+3K163394Hybrid3DHermes Medical Solutions AB20176—
+3K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd.20172—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare201660—
+3K152822VidiStar HeartViewVidistar, LLC20150—
+3K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+3K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis20136—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K123174Centricity Pacs-IW with Universal ViewerGE Healthcare20121510
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—
+4K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—
+4K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+4K241364Hybrid Viewer (00859873006189)Hermes Medical Solutions AB20241—
+4K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+4K220813Art-PlanTherapanacea20224—
+4K212915MVision AI SegmentationMVision AI20221—
+4K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+4K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K202928DV. TargetDeepvoxel, Inc.20210—
+4K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K193403UroNav SystemInvivo Corporation20191—
+4K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+4K182624MIM - MRT DosimetryMim Software, Inc.201853—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K181468Hybrid3DHermes Medical Solutions AB20184—
+4K180077NeuroQ 3.8Syntermed20180—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+4K160357TrinityKoelis20161—
+4K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+4K152716EV Insite SystemPsp Corporation20160—
+4K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+4K150420Centricity Universal ViewerGE Healthcare2015315
+4K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+5K250800UroNav 4Philips DS North America, LLC20250—
+5K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+5K233908cNeuro cDATCombinostics OY20240—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+5K230023ART-PlanTherapanacea Sas20233—
+5K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+5K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+5K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+5K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—