510(k) Report

Devices descending from K072653

51 later devices reach 3VISEON/Surgery through their predicates, nearest generation first.

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