510(k) Report

Devices descending from K962699

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182537RADMAX Digital Imaging SoftwareDRGEM Corporation20190—
+6K183478ClearON MobileRayence Co., Ltd.20190—
+6K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+6K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+6K180522IGTFusionIgi Technologies20180—
+6K181345Image Filing Software NAVIS-EXNidek Co., Ltd.20181—
+6K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc.20181—
+6K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+6K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+6K173636VelocityVarian Medical Systems, Inc.20188—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K173420Radiomics App v1.0Microsoft Corp.20174—
+6K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+6K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+6K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K170729Examion X-AQSExamion GmbH20170—
+6K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+6K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+6K162684SL 220Carl Zeiss Meditec, AG20171—
+6K163564Slit Lamp SL-2000Nidek Co., Ltd.20170—
+6K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+6K162529DigiX FDXAllengers Medical Systems Limited20176—
+6K161607VisuluxCarl Zeiss Meditec, AG20170—
+6K162670RSM 1824C with RConsole1DRTECH Corporation20174—
+6K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+6K162687Paragon 2Meridian Medical Systems, LLC20160—
+6K160371NovaPACSNovarad Corporation20165—
+6K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+6K160284JointPointJointpoint, Inc.201621—
+6K153014Mobius3DMobius Medical Systems, LP201613—
+6K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+6K153653DICOM ViewerBrainlab AG20164—
+6K143514Panther StereoSeedProwess, Inc.20150—
+6K151952Synergy ODMTopcon Medical Systems, Inc.20158—
+6K143397ICIS ViewAgfa Healthcare N.V.20156—
+6K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+6K150746JUSHA-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20150—
+6K143361Mammo WorkstationGE Healthcare20151—
+6K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC20150—
+6K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+6K132853NovapacsNovarad Corp.201462
+6K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+6K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG20148—
+6K140825Delworks DR SystemDel Medical, Inc.20147—
+6K141329RadspaTelerad Tech Private Limited20140—
+6K133966Model-Based Rsa SoftwareHalifax Biomedical, Inc.20140—
+6K132763Advanced ViewerBrainlab AG20141—
+6K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+6K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+6K123082Mobilect ViewerNephosity, Inc.20130—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K123464Callisto EyeCarl Zeiss Meditec, AG20136—
+6K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+6K123357Onq RTSOncology Systems, Inc.20120—
+6K121663ClarityElekta, Ltd.20121—
+6K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K112930Mobile MimMim Software, Inc.201199—
+6K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+6K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+6K111694ASTRACandelis, Inc.20115—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K090546Modification to Nordicice SoftwareNordicimaginglab AS200972—
+6K082493Medical Display, MD205MG-1Nec Display Solutions, Ltd.20080—
+6K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+6K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.20084—
+6K080325IGROKIgrok, LLC20080—
+6K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+6K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation20081—
+6K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd.20084—
+6K073271OrthogonAgfa Healthcare Corporation20070—
+6K072532Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc.20070—
+7K253834Visuref 600Carl Zeiss Vision GmbH20260—
+7K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+7K234076iCare ALTIUS CWCentervue S.P.A.20240—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+7K231662Aid-UIaid20241—
+7K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+7K230023ART-PlanTherapanacea Sas20233—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K211715RetinAI DiscoveryRetinai Medical AG20221—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K212720nordicDSCNordicneurolab AS20222—
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+7K212137X-CleverLg Electronics.Inc20211—
+7K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+7K212515MOVIX DReamyStephanix20210—