510(k) Report

Devices descending from K960265

180 later devices reach Advantage Windows with Functool Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110573Ready ViewGe Healthcare (Ge Medical Systems Scs)2011381
+1K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091—
+1K081556Cadstream, Version 5.0Confirma, Inc.20099—
+1K063505Visualase Envision Software SystemBiotex, Inc.200627—
+1K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A.200632—
+1K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+1K0508623TP Workspace3tp, LLC2005101
+1K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd.200412—
+1K041286Dynacad V1.0Mri Devices Corp.200417—
+1K0313503TP Software Option3tp, LLC2003191
+1K993791CT Perfusion OptionGe Medical Systems, Inc.19990—
+1K980831Image Post-Processing TechniquesPhilips Medical Systems (Cleveland), Inc.19980—
+1K971965Philips EasyvisionPhilips Medical Systems, Inc.199874—
+2K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+2K173744ProFuse CADEigen20181—
+2K170195QuantXQuantitative Insights, Inc.20174—
+2K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+2K121762Cardiac VXGe Medical Systems, LLC2013211
+2K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.20120—
+2K113456Ready ViewGe Healthcare (Ge Medical Systems Scs)20122—
+2K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+2K092954Cadstream Version 5Confirma, Inc.200983
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K081262DC NeuroInvivo Corporation20082—
+2K080762IB Neuro, Version 1.0Imaging Biometrics, LLC20085—
+2K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A.200824—
+2K073167Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC20086—
+2K071328Visualase Thermal Therapy SystemBiotex, Inc.2007261
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+2K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp.2002489
+3K233714BreViewGE Medical Systems SCS20240—
+3K231130TumorSight VizSimBioSys, Inc.20232—
+3K210670BU-CADTaihao Medical, Inc.20213—
+3K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+3K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+3K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+3K173312ProBx SoftwareHarmonus, Inc.20180—
+3K153039MRI Dynamic Analysis PlusEsaote, S.p.A.20167—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+3K143397ICIS ViewAgfa Healthcare N.V.20156—
+3K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+3K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+3K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+3K130228SuiteheartNeosoft, LLC20130—
+3K123302IB ClinicImaging Biometrics, LLC20131—
+3K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+3K120748Speedup Software OptionEsaote, S.p.A.20120—
+3K113701Visia NeuroMeVis Medical Solutions AG20121—
+3K111945Impax Next GenerationAgfa Healthcare N.V.201122
+3K110802A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A.201111—
+3K110373Temporomanibular Coil 15Esaote, S.p.A.20110—
+3K110238G-SCANEsaote, S.p.A.201115—
+3K100670S-Scan, Model 9800020010Esaote, S.p.A.20100—
+3K092469O-Scan MR SystemEsaote, S.p.A.200918—
+3K091444PerfscapeOlea Medical20090—
+3K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+3K081656Visualase Thermal Therapy SystemBiotex, Inc.2008101
+3K062878Ezpacs, Version 3.0Advanced Imaging Solutions, LLC20072—
+3K061421Erad PacsErad, Inc.200614—
+3K050228Agfa Heartlab CardiovascularHeartlab, Inc.2005922
+3K040896Modification to EncompassHeartlab, Inc.200411
+3K040344Impax OT3000 Orthopedic WorkstationAgfa Corp.20042—
+3K031132Consultiva Case Input Station, Model Cis-1Eastman Kodak Company20031—
+3K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+3K031638Cardio Vascular Information Enhanced WorkstationElectromed Imaging, Inc.20030—
+3K031248Consultiva Report Station, Model RS-1Miramedica, Inc.20031—
+4K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+4K260086CadAI-B DxBeamWorks, Inc.20260—
+4K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K243189TumorSight VizSimBioSys, Inc.20241—
+4K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+4K231662Aid-UIaid20241—
+4K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+4K211356GIQuantMotilent, Ltd.20210—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K191125ADAS 3DGalgo Medical S.L20205—
+4K181859Visualase Thermal Therapy SystemMedtronic Navigation, Inc.201991
+4K183685O-ScanEsaote, S.p.A.20190—
+4K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+4K182036NeuroBlate SystemMonteris Medical,201811—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+4K172881NeuroBlate SystemMonteris Medical,201713—
+4K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+4K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+4K163253Arterys Cardio DLArterys, Inc.20174—
+4K162513Arterys Software v2.0Arterys, Inc.20165—
+4K162112Caas MRVPie Medical Imaging BV20162—
+4K161238S-scanEsaote, S.p.A.20166—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K151074Magnetic Reasonance Imaging SystemJiangsu Magspin Instrument Co.,Ltd20150—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K141329RadspaTelerad Tech Private Limited20140—
+4K132799Clariso PacsClariso, Inc.20134—
+4K120561Neuroblate SystemMonteris Medical, Inc.2013211
+4K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+4K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—