510(k) Report

Devices descending from K002936

436 later devices reach Modification to IDS5 Image Display System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+5K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+5K170172UNiD Spine AnalyzerMedicrea International20177—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+5K163221Mazor XMazor Robotics, Ltd.201719—
+5K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+5K161479hipEOSOnefit Medical20169—
+5K160407spineEOSOnefit Medical20166—
+5K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143361Mammo WorkstationGE Healthcare20151—
+5K141137Stereos WorkstationEos Imaging20149—
+5K132742M-VU Breast DensityVucomp, Inc.201311—
+5K121916IntuitionTerarecon,Inc.201351
+5K121213VitreaadvancedVital Images, Inc.201281
+5K120472QuantraHologic, Inc.20123—
+5K102556Volpara, Version 1.3Matakina Technology Limited201024—
+5K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+6K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+6K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+6K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+6K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+6K252214AIAS CephalonMetamorphosis GmbH20250—
+6K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+6K243069Lumys (V1)Intradys20250—
+6K243697MySpine WebPlannerMedacta International S.A.20250—
+6K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+6K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+6K240926PeekMed webPeek Health, S.A.20246—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+6K240172Preview ShoulderGenesis Software Innovations20240—
+6K232086spineEOSEos Imaging20235—
+6K213779Customize3D-Side S.A.20221—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K200274CariCloudCaristo Diagnostics20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+6K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+6K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K180307Mazor XMazor Robotics, Ltd.201817—
+6K173390hipEOSOnefit Medical20188—
+6K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+6K170540DM-DensityDensitas, Inc.20187—
+6K180091UNiD Spine AnalyzerMedicrea International20186—
+6K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+6K172522Mazor XMazor Robotics, Ltd.20170—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K152009DENSEEMAMMO v1.0Statlife20161—
+6K160937SenolrisGE Healthcare20160—
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K160914sterEOS WorkstationEos Imaging, Inc.20168—
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+6K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K142037QuantraHologic, Inc.20141—
+6K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K250290SurgiTwinTwinsight20250—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K250042PeekMed webPeek Health, S.A.20254—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K240582VEA Align; spineEOSEos Imaging20244—
+7K221432Customize3D-Side S.A.20220—
+7K220779XDMirada Medical, Ltd.20220—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+7K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+7K203785ClariSIGMAMClaripi, Inc.20210—
+7K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K201411Visage Breast DensityVisage Imaging GmbH20210—
+7K202700ART-PlanTherapanacea20215—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K200323AutoContourRadformation, Inc.20207—
+7K192973densitas densityaiDensitas, Inc.20205—
+7K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+7K190764SurgicalARMedivis, Inc.20196—
+7K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+7K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K173574DenSeeMammoStatlife20180—
+7K172346sterEOS WorkstationEos Imaging201871
+7K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—