510(k) Report

Devices descending from K002936

436 later devices reach Modification to IDS5 Image Display System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033088Sectra IDS5 Radiology Workstation Version 10.1Sectra AB200301
+1K031590Sectra Orthopedic PackageSectra-Imtec AB2003136—
+1K022881Cedara I-SoftviewCedara Software Corp.20024133
+1K022710SmartpacsTaiwan Electronic Data Processing Corporation20025—
+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
+2K083182Datacom DC PacsDatacom Technology Corp.20092—
+2K082808Imagesvr PacsJaguar Technology Limited20091—
+2K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+2K042816Traumacad 1.2Orthocrat, Ltd.2004129—
+2K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041—
+2K042507UbipacsIcm Co., Ltd.20040—
+2K041500Starpacs Orthopedics SystemInfinitt Co., Ltd.20041—
+2K041366Ipacs OrthoRealtimeimage, Inc.20040—
+2K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp.20042551
+2K033825OrthopacsEtrauma.Com Corp.200404
+3K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+3K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+3K160284JointPointJointpoint, Inc.201621—
+3K152034FS-PacsEc-Web Co., Ltd.20160—
+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
+3K092125Presidio PacsReaonix Security, LLC20090—
+3K080529Stereos WorkstationBiospace Med200814—
+3K081630Mammo WorkstationImage Diagnost International GmbH20084—
+3K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+3K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+3K073271OrthogonAgfa Healthcare Corporation20070—
+3K063327OrthoviewMerdian Technique, Ltd.200613—
+3K060210MediportMaxant Technologies, Inc.20060—
+3K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+3K051813UltrapacsUltrarad Corporation20050—
+4K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+4K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+4K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+4K203651CuptimizeCuptimize, Inc.20213—
+4K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+4K200350MyHip Planner & VerifierMedacta International S.A.20201—
+4K202519OrthoNext Platform SystemOrthofix Srl20201—
+4K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+4K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+4K182464PeekMedPeek Health, S.A.201817—
+4K173329jFit Surgical PlannerJointvue, LLC20170—
+4K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+4K161828kneeEOSOnefit Medical20162—
+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—
+4K133022ZedviewLexi Co., Ltd.201410—
+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—
+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—
+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—
+5K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+5K223841KBA3DS.M.A.I.O20231—
+5K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K213272Formus HipFormus Labs, Ltd.20230—
+5K221725Advanced MyHip PlannerMedacta International S.A.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K222767PeekMed web (v1)Peek Health, S.A.20228—
+5K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+5K213922FX SPSPixee Medical20222—
+5K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+5K210344inVisionOSPrecisionos Technology, Inc.20210—
+5K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+5K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG20210—
+5K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+5K200704ZedViewLexi Co., Ltd.20210—
+5K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+5K210556Preview ShoulderGenesis Software Innovations20213—
+5K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+5K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—