510(k) Report

Devices descending from K962699

848 later devices reach Radworks Medical Imaging Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+7K212291PhoenixSedecal., Sa.202141
+7K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+7K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+7K2029022430MCA with Xmaru WRayence Co., Ltd.20211—
+7K203703I-Q ViewFirst Source, Inc.20210—
+7K203651CuptimizeCuptimize, Inc.20213—
+7K200422Image Quality Analyzer (IQA)Visionquest Biomedical, Inc.20200—
+7K200350MyHip Planner & VerifierMedacta International S.A.20201—
+7K200323AutoContourRadformation, Inc.20207—
+7K202519OrthoNext Platform SystemOrthofix Srl20201—
+7K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+7K201232Limbus ContourLimbus Ai, Inc.20202—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+7K201798myQA iONIba Dosimetry GmbH202011
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K191014Elements ViewerBrainlab AG20203—
+7K192936Soltus 500Sedecal., Sa.201901
+7K192541DigiX FDXAllengers Medical Systems Limited20195—
+7K191610RTappSegana, LLC20191—
+7K191761Mobius3DVarian Medical Systems, Inc.20195—
+7K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+7K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K190764SurgicalARMedivis, Inc.20196—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K182966PLANET Onco DoseDosisoft20191—
+7K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+7K182624MIM - MRT DosimetryMim Software, Inc.201853—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K182016Simplicit90YMirada Medical, Ltd.20183—
+7K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185—
+7K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+7K181501AfinaNeurovision Imaging, LLC20180—
+7K182464PeekMedPeek Health, S.A.201817—
+7K182376HarmonyTopcon Medical Systems, Inc.20184—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+7K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+7K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K171350Collision CheckRadformation, Inc.20174—
+7K173329jFit Surgical PlannerJointvue, LLC20170—
+7K171754NovaPACSNovarad Corporation201741
+7K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+7K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K170930RSM 2430CDRTECH Corporation20171—
+7K163324nordicBrainExNordicneurolab AS20175—
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+7K161828kneeEOSOnefit Medical20162—
+7K161201ClearRead CTRiverain Technologies, LLC20165—
+7K160937SenolrisGE Healthcare20160—
+7K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+7K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+7K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+7K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+7K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+7K142196Visage Ease ProVisage Imaging GmbH20150—
+7K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+7K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+7K142671Onefit Hip PlannerOnefit Medical201410—
+7K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+7K141855ClarityElekta, Ltd.20140—
+7K141669SurgimapNemaris, Inc.201427—
+7K141199Quentry Dose ReviewBrainlab AG20140—
+7K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+7K140434Medicad ClassicHectec GmbH20140—
+7K133521Aze Phoenix SoftwareAze, Ltd.20140—
+7K133910NordicbrainexNordicneurolab201452
+7K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K13113721.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)Jvckenwood Corporation20131—
+7K130278MR PermeabilityPhilips Medical Systems Nederland B.V.20131—
+7K123306Nordic TumorexNordicneurolab201301
+7K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+7K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K123302IB ClinicImaging Biometrics, LLC20131—
+7K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+7K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation20122—
+7K113620Myrian 1.11Intrasense20126—
+7K120196Olea SphereOlea Medical201251—
+7K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+7K120115OrthosizeOrthosize, LLC201201
+7K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd.20112—
+7K111161Perfscape V2.0Olea Medical201153—
+7K111019Surgimap (TM) SpineNemaris, Inc.201151—
+7K101796Pacsmate MMD-5201M MonitorIei Technology Corp.20100—
+7K092102Nordicbrainex Software, Version 1.0Nordicimaginglab AS200901
+7K081556Cadstream, Version 5.0Confirma, Inc.20099—
+7K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.20083—
+8K260597Virtue QAProNova Solutions20260—
+8K261861SPINEsim v1.0Mdsim S.A.20260—
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K2613522D Hip Planning SoftwareOne Ortho20260—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—