510(k) Report

Devices descending from K000395

207 later devices reach Einstein Processing and Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024137Jupiter Processing and Review WorkstationGe Medical Systems, Inc.20031932
+1K022240Mobile Millennium MG SystemGe Medical Systems, Inc.200211—
+1K014058Entegra PE Personal Digital AssistantGeneral Electric Medical Systems20010—
+2K090811Inspira HD, Model: NL1000Neurologica Corporation200910—
+2K051673Xeleris 2 Processing and Review WorkstationGE Medical Systems20051923
+3K131233Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB201316—
+3K102677Bodytom NL 4000Neurologica Corporation20119—
+3K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa20101341
+3K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd.20091—
+3K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+3K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions2008187
+3K0810933-D Imaging WorkstationEigen, LLC200831—
+3K061587Fullcard AnalysisGE Healthcare20061—
+4K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+4K222683Fibroid Mapping Reviewer Application (FMRA)Nesa Medtech Private Limited20230—
+4K192277CardIQ FlowGE Medical Systems SCS20200—
+4K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics20174—
+4K162474ArtemisEigen20163—
+4K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB201610—
+4K153166Fusion BxFocal Healtcare, Inc.20161—
+4K153073UroNav (Version 2.0)Invivo Corporation201511—
+4K142697NExCT 7Neurologica Corporation20140—
+4K142631Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB201411—
+4K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415—
+4K131431Airo CT SystemMobius Imaging, LLC201321
+4K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K122329BiojetJet Soft Srl20120—
+4K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+4K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions2012161
+4K100784UC-Care Navigo SytemUC-CARE, Ltd.20113—
+4K103710WBR Xpress PetUltraspect, Ltd.20110—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K100793Urostation 3D Prostate SuiteKoelis20107—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+4K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+5K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company20260—
+5K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd.20221—
+5K213649BodyTom 64Neurologica Corporation20222—
+5K220779XDMirada Medical, Ltd.20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K182561UroNav (Version 3.0)Invivo Corporation20182—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K181290Fusion Bx 2.0Focal Healthcare, Inc.20180—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+5K171681Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB201721
+5K171719Hybrid3DHermes Medical Solutions AB20175—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+5K170250SmartTargetSmarttarget, Ltd.201701
+5K163394Hybrid3DHermes Medical Solutions AB20176—
+5K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd.20172—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K160126AIRO Computed Tomography (CT) X-ray SystemMobius Imaging201612
+5K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare201660—
+5K152822VidiStar HeartViewVidistar, LLC20150—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis20136—
+5K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+5K123174Centricity Pacs-IW with Universal ViewerGE Healthcare20121510
+5K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—
+6K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—
+6K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+6K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+6K241364Hybrid Viewer (00859873006189)Hermes Medical Solutions AB20241—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K193403UroNav SystemInvivo Corporation20191—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182624MIM - MRT DosimetryMim Software, Inc.201853—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181468Hybrid3DHermes Medical Solutions AB20184—
+6K180077NeuroQ 3.8Syntermed20180—
+6K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+6K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+6K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+6K160357TrinityKoelis20161—
+6K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+6K152716EV Insite SystemPsp Corporation20160—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K150420Centricity Universal ViewerGE Healthcare2015315
+6K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+6K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+7K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—