510(k) Report

Devices descending from K904519

438 later devices reach Agfa Diagnostic Center (Adc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072766Pvmed DDR 2520 Digital Imaging SystemPortavision Medical20070—
+1K974597Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div.19984361
+2K061538Alara Crystalview Computed Radiography System, Model R200Alara, Inc.20061—
+2K032210Alara Crystalview Computed Radiography SystemAlara, Inc.20032—
+2K012750Adc PediatricAgfa Corp.20010—
+2K013138Adc Compact PlusAgfa-Gevaert AG2001431—
+3K102619Computed Raddiography Scanner3Disc Americas20113—
+3K062390Crystalview R200Alara, Inc.20060—
+3K041701Afga CR25.0 Computed Radiography SystemAgfa Corp.200412—
+3K022881Cedara I-SoftviewCedara Software Corp.20024133
+3K021542Adc DentalAgfa Corp.20020—
+4K163048Smart Stitching Software System, Image Processing, RadiologicalOsko, Inc.20170—
+4K133106Computed Radiography Scanner3Disc Americas20140—
+4K133120Computed Radiography Scanner3Disc Americas20140—
+4K131408CR 12-X DigitizerAgfa Healthcare N.V.20130—
+4K130567DR Long Length Imaging SoftwareCarestream Health, Inc.20130—
+4K092915Cedara Webaccess, Model: 2.4Cedara Software Corp.2010214
+4K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+4K062223Agfa Model CR30-XAgfa Corporation20068—
+4K050810Agfa CR50.0Agfa Corp.200502
+4K042779Radiotherapy Solution Based on CRAgfa Corp.20041—
+4K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp.20042551
+4K033825OrthopacsEtrauma.Com Corp.200404
+5K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+5K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+5K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+5K140434Medicad ClassicHectec GmbH20140—
+5K121948CR 10-X DigitizerAgfa Healthcare N.V.201211
+5K111945Impax Next GenerationAgfa Healthcare N.V.201122
+5K111892Vitreaview Software 6.1Vital Images, Inc.201116—
+5K101398Stereos WorkstationBiospace Med2011121
+5K080529Stereos WorkstationBiospace Med200814—
+5K081630Mammo WorkstationImage Diagnost International GmbH20084—
+5K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+5K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+5K073271OrthogonAgfa Healthcare Corporation20070—
+5K072010Quantum Direx SystemQuantum Medical Imaging, LLC20075—
+5K070920Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc.20070—
+5K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+6K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+6K202519OrthoNext Platform SystemOrthofix Srl20201—
+6K182464PeekMedPeek Health, S.A.201817—
+6K173329jFit Surgical PlannerJointvue, LLC20170—
+6K161828kneeEOSOnefit Medical20162—
+6K160284JointPointJointpoint, Inc.201621—
+6K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+6K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K142671Onefit Hip PlannerOnefit Medical201410—
+6K141669SurgimapNemaris, Inc.201427—
+6K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+6K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+6K130395Stereos WorkstationEos Imaging, Inc.2013101
+6K123575MammoworkstationImage Diagnost International GmbH20132—
+6K113344Stereos WorkstationEos Imaging201211—
+6K122136VitreaviewVital Images, Inc.201215—
+6K120115OrthosizeOrthosize, LLC201201
+6K111019Surgimap (TM) SpineNemaris, Inc.201151—
+6K090050Stereos WorkstationBiospace Med201013—
+6K092954Cadstream Version 5Confirma, Inc.200983
+6K082483QuantraHologic, Inc.200825—
+6K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC20084—
+6K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+6K071241LMS-LiverMedian Technologies20079—
+7K261861SPINEsim v1.0Mdsim S.A.20260—
+7K2613522D Hip Planning SoftwareOne Ortho20260—
+7K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+7K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+7K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+7K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+7K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+7K242270OrthoNext Platform SystemOrthofix Srl20240—
+7K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+7K231130TumorSight VizSimBioSys, Inc.20232—
+7K231498TraumaCad NeoBrainlab, Ltd.20231—
+7K230252OFIX MIS AppOrthofix US, LLC20230—
+7K223841KBA3DS.M.A.I.O20231—
+7K213272Formus HipFormus Labs, Ltd.20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K222767PeekMed web (v1)Peek Health, S.A.20228—
+7K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+7K210344inVisionOSPrecisionos Technology, Inc.20210—
+7K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+7K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+7K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+7K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+7K210556Preview ShoulderGenesis Software Innovations20213—
+7K203651CuptimizeCuptimize, Inc.20213—
+7K200350MyHip Planner & VerifierMedacta International S.A.20201—
+7K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+7K193574Q-Rad SystemCarestream Health, Inc.20203—
+7K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+7K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+7K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+7K170172UNiD Spine AnalyzerMedicrea International20177—
+7K170195QuantXQuantitative Insights, Inc.20174—
+7K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+7K163221Mazor XMazor Robotics, Ltd.201719—