510(k) Report

Devices descending from K013878

140 later devices reach Cybermed, Inc., V-Works through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061126AccurexCybermed, Inc.20063—
+1K053155VimplantCybermed, Inc.200563—
+1K033955RTISTMirada Solutions, Ltd.200475—
+2K101228Mirada XDMirada Medical, Ltd.201070—
+2K090607Blue Sky Bio Plan, Version .38Blue Sky Bio, LLC20092—
+2K081215VoluminaKjaya Medical, LLC20080—
+2K071636Codiagnostix (R) 5.72Ivs Solutions AG2007212
+2K070803InvivodentalAnatomage, Inc.200738—
+2K061418QuantivaTomographix IP, Ltd.20060—
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K220779XDMirada Medical, Ltd.20220—
+3K190096R2GATEMegagen Implant Co., Ltd.20191—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+3K170180Will3DHdx Will Corp.20171—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K130242Maven ProNsequence20130—
+3K130724Codiagnostix Implant Planning SoftwareStraumann USA201315—
+3K123519Invivo DentalAnatomage, Inc.201324—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+3K112251Swissmeda Dental Planning SystemSwissmeda AG20124—
+3K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+3K113543ONDEMAND3DCybermed, Inc.20119—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+4K232698NemoScanSoftware Nemotec S.L.20240—
+4K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—
+4K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+4K211114Will3DHdx Will Corp.20210—
+4K210241ImplaStationProdigident, Inc.20210—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K193301coDiagnostiXDental Wings GmbH20210—
+4K200572Planmeca RomexisPlanmeca Oy20202—
+4K2022563Shape Implant Studio3Shape Medical A/S20201—
+4K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K181926InVivo Web ViewerAnatomage, Inc.20180—
+4K171385Planmeca RomexisPlanmeca Oy20171—
+4K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+4K151152ImplantMax SoftwareSaturn Imaging, Inc.20160—
+4K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+4K152078Implant Studio 20153Shape Medical A/S20157—
+4K141570Implant Studio3Shape Medical A/S20148—
+4K140713Planmeca RomexisPlanmeca Oy201414—
+4K140093TABLEAnatomage, Inc.20144—
+4K132773Sidexis 4Sirona Dental Systems GmbH20131—
+4K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+4K123976NobelclinicianNobel Biocare AB20133—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+5K253902RealGUIDE3DIEMME SRL20260—
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K260716NeowiseCefla S.C.20260—
+5K251514Overjet CBCT AssistOverjet, Inc.20250—
+5K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+5K230012Atomica PlannerAtomica Technology, Inc.20230—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K200078VARO Plan3D Industrial Imaging Co., Ltd.20200—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+5K183458exoplan 2.3Exocad GmbH20191—
+5K190232Synapse PACSFujifilm Corporation2019311
+5K1730413DIEMME RealGUIDE3Diemme, Ltd.20182—
+5K180629DentiqGuide3D Industrial Imaging Co., Ltd.20181—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173475Merge PACSMerge Healthcare Incorporated201712
+5K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+5K163668SuitestensaEbit Srl20170—
+5K162799CliniviewPalodex Group OY201713—
+5K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+5K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+5K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+5K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+6K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K213302exoplanExocad GmbH202201
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter…Zirkonzahn Srl20210—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K203156DTX Studio ClinicNobel Biocare AB202010—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+6K192455Merge PACSMerge Healthcare Incorporated201904
+6K180192Emprint Ablation Visualization ApplicationCovidien, LLC20182—
+6K172224DTX Studio diagnoseNobel Biocare AB20180—
+6K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K230023ART-PlanTherapanacea Sas20233—