510(k) Report

Devices descending from K941933

414 later devices reach Isg Medical Imaging Family of Workstations (Mifw) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022881Cedara I-SoftviewCedara Software Corp.20024133
+2K163048Smart Stitching Software System, Image Processing, RadiologicalOsko, Inc.20170—
+2K130567DR Long Length Imaging SoftwareCarestream Health, Inc.20130—
+2K092915Cedara Webaccess, Model: 2.4Cedara Software Corp.2010214
+2K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+2K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp.20042551
+2K033825OrthopacsEtrauma.Com Corp.200404
+3K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+3K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+3K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+3K140434Medicad ClassicHectec GmbH20140—
+3K111945Impax Next GenerationAgfa Healthcare N.V.201122
+3K111892Vitreaview Software 6.1Vital Images, Inc.201116—
+3K101398Stereos WorkstationBiospace Med2011121
+3K080529Stereos WorkstationBiospace Med200814—
+3K081630Mammo WorkstationImage Diagnost International GmbH20084—
+3K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+3K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+3K073271OrthogonAgfa Healthcare Corporation20070—
+3K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+4K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+4K202519OrthoNext Platform SystemOrthofix Srl20201—
+4K182464PeekMedPeek Health, S.A.201817—
+4K173329jFit Surgical PlannerJointvue, LLC20170—
+4K161828kneeEOSOnefit Medical20162—
+4K160284JointPointJointpoint, Inc.201621—
+4K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+4K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K142671Onefit Hip PlannerOnefit Medical201410—
+4K141669SurgimapNemaris, Inc.201427—
+4K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+4K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+4K130395Stereos WorkstationEos Imaging, Inc.2013101
+4K123575MammoworkstationImage Diagnost International GmbH20132—
+4K113344Stereos WorkstationEos Imaging201211—
+4K122136VitreaviewVital Images, Inc.201215—
+4K120115OrthosizeOrthosize, LLC201201
+4K111019Surgimap (TM) SpineNemaris, Inc.201151—
+4K090050Stereos WorkstationBiospace Med201013—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K082483QuantraHologic, Inc.200825—
+4K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+4K071241LMS-LiverMedian Technologies20079—
+5K261861SPINEsim v1.0Mdsim S.A.20260—
+5K2613522D Hip Planning SoftwareOne Ortho20260—
+5K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+5K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+5K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+5K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+5K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+5K242270OrthoNext Platform SystemOrthofix Srl20240—
+5K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K231498TraumaCad NeoBrainlab, Ltd.20231—
+5K230252OFIX MIS AppOrthofix US, LLC20230—
+5K223841KBA3DS.M.A.I.O20231—
+5K213272Formus HipFormus Labs, Ltd.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K222767PeekMed web (v1)Peek Health, S.A.20228—
+5K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+5K210344inVisionOSPrecisionos Technology, Inc.20210—
+5K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+5K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+5K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+5K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+5K210556Preview ShoulderGenesis Software Innovations20213—
+5K203651CuptimizeCuptimize, Inc.20213—
+5K200350MyHip Planner & VerifierMedacta International S.A.20201—
+5K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+5K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+5K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+5K170172UNiD Spine AnalyzerMedicrea International20177—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+5K163221Mazor XMazor Robotics, Ltd.201719—
+5K161479hipEOSOnefit Medical20169—
+5K160407spineEOSOnefit Medical20166—
+5K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143361Mammo WorkstationGE Healthcare20151—
+5K141137Stereos WorkstationEos Imaging20149—
+5K132742M-VU Breast DensityVucomp, Inc.201311—
+5K121916IntuitionTerarecon,Inc.201351
+5K121213VitreaadvancedVital Images, Inc.201281
+5K120472QuantraHologic, Inc.20123—
+5K102556Volpara, Version 1.3Matakina Technology Limited201024—
+5K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+6K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+6K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+6K243069Lumys (V1)Intradys20250—
+6K243697MySpine WebPlannerMedacta International S.A.20250—
+6K240926PeekMed webPeek Health, S.A.20246—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+6K240172Preview ShoulderGenesis Software Innovations20240—
+6K232086spineEOSEos Imaging20235—