510(k) Report

Devices descending from K913475

181 later devices reach Magnetic Resonance Diagnostic Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+5K121650S-SCANEsaote, S.p.A.201210—
+5K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+5K111803G-SCANEsaote, S.p.A.201114—
+5K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+5K061160M-VU Cad StationVucomp, Inc.20060—
+5K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc.200572
+5K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+5K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050—
+5K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041—
+6K250039HPACSHealthhub20250—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+6K241223eRAD PACSErad, Inc.20240—
+6K233457RUSHutom, Inc.20240—
+6K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+6K231061NeuroBlate SystemMonteris Medical,20236—
+6K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB20227—
+6K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+6K210850ADAS 3DAdas3D Medical S.L.20214—
+6K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+6K200822BraidBraid.Health20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K193375NeuroBlate SystemMonteris Medical,202010—
+6K182034Arterys MICAArterys, Inc.20183—
+6K173305NeuroBlate SystemMonteris Medical,201712—
+6K170724NeuroBlate SystemMonteris Medical,201715—
+6K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+6K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+6K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+6K152977DG PacsDicom Grid, Inc.201641
+6K151957BOX DICOM ViewerBox, Inc.20153—
+6K142421G-scan BrioEsaote, S.p.A.201591
+6K141983Neuroblate SystemMonteris Medical Corp.2014182
+6K131996S-SCANEsaote, S.p.A.20139—
+6K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+6K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+6K120288Orthocad Software OptionEsaote, S.p.A.20120—
+6K122006G-Scan BrioEsaote, S.p.A.201211—
+6K111319Ibis Explorer and Markup SoftwareMedqia20116—
+6K060210MediportMaxant Technologies, Inc.20060—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+7K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+7K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+7K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+7K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+7K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+7K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+7K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+7K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+7K212421ADAS 3DAdas3D Medical S.L.20213—
+7K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+7K201296i-Rapha SolutionIrm, Inc.20200—
+7K192437Arterys MICAArterys, Inc.20202—
+7K180549ZED LinkZed Technologies20180—
+7K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+7K151668S-scanEsaote, S.p.A.20158—
+7K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+7K133490G-Scan BrioEsaote, S.p.A.201310—
+7K122205EXINIExini Diagnostics AB20125—
+8K262315NeuroBlate SystemMonteris Medical20260—
+8K261331I-Genius (100019400)Esaote, S.p.A.20260—
+8K260976NeuroBlate SystemMonteris Medical20261—
+8K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+8K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+8K231360Ambra PACSDicom Grid Dba Ambra Health202301
+8K230803ADAS 3DAdas3D Medical S.L.20232—
+8K203744Arterys MICAArterys, Inc.20221—
+8K191262aBSIExini Diagnostics AB20192—
+8K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+9K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+9K252539Tempus PixelArterys, Inc.20250—
+9K240791ADAS 3DAdas3D Medical S.L.20241—
+9K233998TRAQinform IQAiq Global, Inc.20240—
+9K211655aPROMISEExini Diagnostics AB20211—
+10K253969ADAS 3DAdas3D Medical S.L.20260—
+10K220590aPROMISE XExini Diagnostics AB20220—