510(k) Report

Devices descending from K960265

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121650S-SCANEsaote, S.p.A.201210—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K111803G-SCANEsaote, S.p.A.201114—
+4K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+4K061160M-VU Cad StationVucomp, Inc.20060—
+4K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc.200572
+4K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+4K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050—
+4K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041—
+5K250039HPACSHealthhub20250—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K251766TumorSight VizSimBioSys, Inc.20250—
+5K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+5K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+5K241223eRAD PACSErad, Inc.20240—
+5K233457RUSHutom, Inc.20240—
+5K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+5K231061NeuroBlate SystemMonteris Medical,20236—
+5K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB20227—
+5K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+5K210850ADAS 3DAdas3D Medical S.L.20214—
+5K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+5K200822BraidBraid.Health20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K193375NeuroBlate SystemMonteris Medical,202010—
+5K182034Arterys MICAArterys, Inc.20183—
+5K173305NeuroBlate SystemMonteris Medical,201712—
+5K170724NeuroBlate SystemMonteris Medical,201715—
+5K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+5K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+5K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+5K152977DG PacsDicom Grid, Inc.201641
+5K151957BOX DICOM ViewerBox, Inc.20153—
+5K142421G-scan BrioEsaote, S.p.A.201591
+5K141983Neuroblate SystemMonteris Medical Corp.2014182
+5K131996S-SCANEsaote, S.p.A.20139—
+5K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+5K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+5K120288Orthocad Software OptionEsaote, S.p.A.20120—
+5K122006G-Scan BrioEsaote, S.p.A.201211—
+5K111319Ibis Explorer and Markup SoftwareMedqia20116—
+5K060210MediportMaxant Technologies, Inc.20060—
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+6K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+6K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+6K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+6K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+6K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+6K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+6K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+6K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+6K212421ADAS 3DAdas3D Medical S.L.20213—
+6K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+6K201296i-Rapha SolutionIrm, Inc.20200—
+6K192437Arterys MICAArterys, Inc.20202—
+6K180549ZED LinkZed Technologies20180—
+6K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+6K151668S-scanEsaote, S.p.A.20158—
+6K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+6K133490G-Scan BrioEsaote, S.p.A.201310—
+6K122205EXINIExini Diagnostics AB20125—
+7K262315NeuroBlate SystemMonteris Medical20260—
+7K261331I-Genius (100019400)Esaote, S.p.A.20260—
+7K260976NeuroBlate SystemMonteris Medical20261—
+7K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+7K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+7K231360Ambra PACSDicom Grid Dba Ambra Health202301
+7K230803ADAS 3DAdas3D Medical S.L.20232—
+7K203744Arterys MICAArterys, Inc.20221—
+7K191262aBSIExini Diagnostics AB20192—
+7K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+8K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+8K252539Tempus PixelArterys, Inc.20250—
+8K240791ADAS 3DAdas3D Medical S.L.20241—
+8K233998TRAQinform IQAiq Global, Inc.20240—
+8K211655aPROMISEExini Diagnostics AB20211—
+9K253969ADAS 3DAdas3D Medical S.L.20260—
+9K220590aPROMISE XExini Diagnostics AB20220—