510(k) Report

Devices descending from K071964

287 later devices reach Mim 4.1 (Seastar) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202700ART-PlanTherapanacea20215—
+1K190379MIM on LinuxMim Software, Inc.201914—
+1K182855ProKnow DSProknow, LLC20192—
+1K120851Communify Pacs ViewerCommunify Health, LLC20130—
+1K111332Clarity Obp SystemElekta, Ltd.20122—
+1K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+1K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+1K101228Mirada XDMirada Medical, Ltd.201070—
+1K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+1K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+2K251363ProKnow DSElekta Solutions AB20250—
+2K233572AutofusePymedix20240—
+2K223800MIM – Additional TracersMim Software, Inc.20231—
+2K220256MIM-AblationMim Software, Inc.20224—
+2K220813Art-PlanTherapanacea20224—
+2K220779XDMirada Medical, Ltd.20220—
+2K193252Contour ProtegeAIMim Software, Inc.20206—
+2K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+2K180522IGTFusionIgi Technologies20180—
+2K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+2K173636VelocityVarian Medical Systems, Inc.20188—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K173420Radiomics App v1.0Microsoft Corp.20174—
+2K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+2K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K153014Mobius3DMobius Medical Systems, LP201613—
+2K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+2K143514Panther StereoSeedProwess, Inc.20150—
+2K130393Mirada RTXMirada Medical, Ltd.201336—
+2K121663ClarityElekta, Ltd.20121—
+2K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+2K102687Mirada RTMirada Medical, Ltd.201037—
+2K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+2K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+3K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+3K232514MIM – Dose AnalysisMim Software, Inc.20240—
+3K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+3K230023ART-PlanTherapanacea Sas20233—
+3K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+3K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+3K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+3K210632Contour ProtegeAIMim Software, Inc.20215—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K200323AutoContourRadformation, Inc.20207—
+3K201232Limbus ContourLimbus Ai, Inc.20202—
+3K201798myQA iONIba Dosimetry GmbH202011
+3K191610RTappSegana, LLC20191—
+3K191761Mobius3DVarian Medical Systems, Inc.20195—
+3K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+3K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+3K182966PLANET Onco DoseDosisoft20191—
+3K182624MIM - MRT DosimetryMim Software, Inc.201853—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K182016Simplicit90YMirada Medical, Ltd.20183—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K181572Workflow BoxMirada Medical, Ltd.201825—
+3K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+3K173542Arterys Oncology DLArterys, Inc.20185—
+3K171350Collision CheckRadformation, Inc.20174—
+3K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+3K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+3K161201ClearRead CTRiverain Technologies, LLC20165—
+3K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+3K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+3K141855ClarityElekta, Ltd.20140—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+3K113620Myrian 1.11Intrasense20126—
+3K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+3K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+3K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K260597Virtue QAProNova Solutions20260—
+4K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+4K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+4K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+4K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+4K242919V5med Lung AIV5med, Inc.20250—
+4K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+4K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+4K232479ART-PlanTherapanacea20232—
+4K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+4K230575Limbus ContourLimbus Ai, Inc.20231—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+4K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+4K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+4K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+4K212915MVision AI SegmentationMVision AI20221—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K213976Contour ProtégéAIMim Software, Inc.20224—
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+4K210831OnQ NeuroCortechs Labs, Inc.20213—
+4K212887RTappSegana, Inc.20210—
+4K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K202928DV. TargetDeepvoxel, Inc.20210—
+4K203235VBrainVysioneer, Inc.20214—