510(k) Report

Devices descending from K013531

307 later devices reach Qwiksim Virtual Simulation System; Version 2.00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083591Ikoengelo, Version 2Ikoetech, LLC200819—
+1K061006IkoengeloIkoetech, LLC2006299—
+2K111332Clarity Obp SystemElekta, Ltd.20122—
+2K112778Smart Segmentation-Knowledge Based ContouringVarian Medical Systems20115—
+2K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+2K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+2K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc.200829—
+2K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+2K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+3K202700ART-PlanTherapanacea20215—
+3K190379MIM on LinuxMim Software, Inc.201914—
+3K182855ProKnow DSProknow, LLC20192—
+3K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+3K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+3K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K133227Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc.20144—
+3K120851Communify Pacs ViewerCommunify Health, LLC20130—
+3K121663ClarityElekta, Ltd.20121—
+3K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+3K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+3K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+3K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+3K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+3K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+4K251363ProKnow DSElekta Solutions AB20250—
+4K233572AutofusePymedix20240—
+4K223800MIM – Additional TracersMim Software, Inc.20231—
+4K220256MIM-AblationMim Software, Inc.20224—
+4K220813Art-PlanTherapanacea20224—
+4K220779XDMirada Medical, Ltd.20220—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+4K180522IGTFusionIgi Technologies20180—
+4K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+4K173636VelocityVarian Medical Systems, Inc.20188—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+4K173420Radiomics App v1.0Microsoft Corp.20174—
+4K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153014Mobius3DMobius Medical Systems, LP201613—
+4K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+4K143514Panther StereoSeedProwess, Inc.20150—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K141855ClarityElekta, Ltd.20140—
+4K141248Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc.20143—
+4K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+5K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+5K232514MIM – Dose AnalysisMim Software, Inc.20240—
+5K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+5K230023ART-PlanTherapanacea Sas20233—
+5K212274INT ContourCarina Medical, LLC20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203469AI SegmentationVarian Medical Systems, Inc.20211—
+5K200323AutoContourRadformation, Inc.20207—
+5K201232Limbus ContourLimbus Ai, Inc.20202—
+5K201798myQA iONIba Dosimetry GmbH202011
+5K191610RTappSegana, LLC20191—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K191761Mobius3DVarian Medical Systems, Inc.20195—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K182966PLANET Onco DoseDosisoft20191—
+5K182624MIM - MRT DosimetryMim Software, Inc.201853—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K182016Simplicit90YMirada Medical, Ltd.20183—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K171350Collision CheckRadformation, Inc.20174—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K113620Myrian 1.11Intrasense20126—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K260597Virtue QAProNova Solutions20260—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—