510(k) Report

Devices descending from K043097

52 later devices reach 3VISEON through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0726533VISEON/Surgery3Mensio Medical Imaging BV200851—
+2K1203673MENSIO WorkstationPie Medical Imaging BV201249—
+2K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+3K1537363mensio WorkstationPie Medical Imaging BV2016191
+3K141475EndosizeTherenva Sas201416—
+3K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+3K122578Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) PlanningVital Images, Inc.20135—
+4K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc.20260—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K2503303mensio WorkstationPie Medical Imaging BV202501
+4K242500LaralabLaralab GmbH20250—
+4K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+4K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+4K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+4K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+4K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+4K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+4K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+4K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K190874Materialise Mimics EnlightMaterialise NV20192—
+4K160376EndoSizeTherenva Sas201613—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+5K260300WatchMate SoftwareAnumana, Inc.20260—
+5K252195ARTICOR plannerArtiness S.R.L20260—
+5K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+5K252500CARA SystemCara Medical, Ltd.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K242166TribusConnectTribusmed Beheer BV20250—
+5K233217Mimics Cardiac PlannerMaterialise NV20240—
+5K222070EndoNautTherenva Sas20221—
+5K220039AutoSegAi Medic, Inc.20221—
+5K220727inHEART MODELSInheart, Sas20221—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K171534SurgicalPreviewEndo Vantage, LLC201710—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+6K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+6K231683inHEART ModelsInheart, Sas20240—
+6K211713AngioCloud ServiceAngiocloud, LLC20220—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K190049Sim&SizeSim&Cure20198—
+7K230006AnkyrasMentice Spain S.L.20231—
+7K202322Sim&SizeSim&Cure20205—
+8K250160AnkyrasMentice Spain S.L.20250—
+8K213838AneuGuideArteryFlow Technology Co., Ltd.20220—
+8K212373Sim&SizeSim&Cure20223—
+9K222664Sim&SizeSim&Cure20232—
+10K242124Sim&SizeSim&Cure20241—
+11K253122Sim&SizeSim&Cure20250—