510(k) Report

Devices descending from K061006

299 later devices reach Ikoengelo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+1K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc.200829—
+1K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+1K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+2K202700ART-PlanTherapanacea20215—
+2K190379MIM on LinuxMim Software, Inc.201914—
+2K182855ProKnow DSProknow, LLC20192—
+2K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+2K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+2K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+2K120851Communify Pacs ViewerCommunify Health, LLC20130—
+2K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+2K111332Clarity Obp SystemElekta, Ltd.20122—
+2K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+2K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+2K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+2K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+2K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+2K101228Mirada XDMirada Medical, Ltd.201070—
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+3K251363ProKnow DSElekta Solutions AB20250—
+3K233572AutofusePymedix20240—
+3K223800MIM – Additional TracersMim Software, Inc.20231—
+3K220256MIM-AblationMim Software, Inc.20224—
+3K220813Art-PlanTherapanacea20224—
+3K220779XDMirada Medical, Ltd.20220—
+3K193252Contour ProtegeAIMim Software, Inc.20206—
+3K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+3K180522IGTFusionIgi Technologies20180—
+3K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+3K173636VelocityVarian Medical Systems, Inc.20188—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+3K173420Radiomics App v1.0Microsoft Corp.20174—
+3K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+3K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K153014Mobius3DMobius Medical Systems, LP201613—
+3K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+3K143514Panther StereoSeedProwess, Inc.20150—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+3K130393Mirada RTXMirada Medical, Ltd.201336—
+3K121663ClarityElekta, Ltd.20121—
+3K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+3K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+3K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+4K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+4K232514MIM – Dose AnalysisMim Software, Inc.20240—
+4K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+4K230023ART-PlanTherapanacea Sas20233—
+4K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+4K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+4K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+4K210632Contour ProtegeAIMim Software, Inc.20215—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K200323AutoContourRadformation, Inc.20207—
+4K201232Limbus ContourLimbus Ai, Inc.20202—
+4K201798myQA iONIba Dosimetry GmbH202011
+4K191610RTappSegana, LLC20191—
+4K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+4K191761Mobius3DVarian Medical Systems, Inc.20195—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+4K182966PLANET Onco DoseDosisoft20191—
+4K182624MIM - MRT DosimetryMim Software, Inc.201853—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K182016Simplicit90YMirada Medical, Ltd.20183—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+4K173542Arterys Oncology DLArterys, Inc.20185—
+4K171350Collision CheckRadformation, Inc.20174—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+4K141855ClarityElekta, Ltd.20140—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K113620Myrian 1.11Intrasense20126—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K260597Virtue QAProNova Solutions20260—
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+5K242919V5med Lung AIV5med, Inc.20250—
+5K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+5K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+5K232479ART-PlanTherapanacea20232—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—