510(k) Report

Devices descending from K974597

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061538Alara Crystalview Computed Radiography System, Model R200Alara, Inc.20061—
+1K032210Alara Crystalview Computed Radiography SystemAlara, Inc.20032—
+1K012750Adc PediatricAgfa Corp.20010—
+1K013138Adc Compact PlusAgfa-Gevaert AG2001431—
+2K102619Computed Raddiography Scanner3Disc Americas20113—
+2K062390Crystalview R200Alara, Inc.20060—
+2K041701Afga CR25.0 Computed Radiography SystemAgfa Corp.200412—
+2K022881Cedara I-SoftviewCedara Software Corp.20024133
+2K021542Adc DentalAgfa Corp.20020—
+3K163048Smart Stitching Software System, Image Processing, RadiologicalOsko, Inc.20170—
+3K133106Computed Radiography Scanner3Disc Americas20140—
+3K133120Computed Radiography Scanner3Disc Americas20140—
+3K131408CR 12-X DigitizerAgfa Healthcare N.V.20130—
+3K130567DR Long Length Imaging SoftwareCarestream Health, Inc.20130—
+3K092915Cedara Webaccess, Model: 2.4Cedara Software Corp.2010214
+3K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+3K062223Agfa Model CR30-XAgfa Corporation20068—
+3K050810Agfa CR50.0Agfa Corp.200502
+3K042779Radiotherapy Solution Based on CRAgfa Corp.20041—
+3K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp.20042551
+3K033825OrthopacsEtrauma.Com Corp.200404
+4K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+4K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+4K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+4K140434Medicad ClassicHectec GmbH20140—
+4K121948CR 10-X DigitizerAgfa Healthcare N.V.201211
+4K111945Impax Next GenerationAgfa Healthcare N.V.201122
+4K111892Vitreaview Software 6.1Vital Images, Inc.201116—
+4K101398Stereos WorkstationBiospace Med2011121
+4K080529Stereos WorkstationBiospace Med200814—
+4K081630Mammo WorkstationImage Diagnost International GmbH20084—
+4K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+4K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+4K073271OrthogonAgfa Healthcare Corporation20070—
+4K072010Quantum Direx SystemQuantum Medical Imaging, LLC20075—
+4K070920Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc.20070—
+4K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+5K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+5K202519OrthoNext Platform SystemOrthofix Srl20201—
+5K182464PeekMedPeek Health, S.A.201817—
+5K173329jFit Surgical PlannerJointvue, LLC20170—
+5K161828kneeEOSOnefit Medical20162—
+5K160284JointPointJointpoint, Inc.201621—
+5K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+5K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142671Onefit Hip PlannerOnefit Medical201410—
+5K141669SurgimapNemaris, Inc.201427—
+5K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+5K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+5K130395Stereos WorkstationEos Imaging, Inc.2013101
+5K123575MammoworkstationImage Diagnost International GmbH20132—
+5K113344Stereos WorkstationEos Imaging201211—
+5K122136VitreaviewVital Images, Inc.201215—
+5K120115OrthosizeOrthosize, LLC201201
+5K111019Surgimap (TM) SpineNemaris, Inc.201151—
+5K090050Stereos WorkstationBiospace Med201013—
+5K092954Cadstream Version 5Confirma, Inc.200983
+5K082483QuantraHologic, Inc.200825—
+5K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC20084—
+5K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+5K071241LMS-LiverMedian Technologies20079—
+6K261861SPINEsim v1.0Mdsim S.A.20260—
+6K2613522D Hip Planning SoftwareOne Ortho20260—
+6K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+6K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+6K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+6K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+6K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+6K242270OrthoNext Platform SystemOrthofix Srl20240—
+6K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K231498TraumaCad NeoBrainlab, Ltd.20231—
+6K230252OFIX MIS AppOrthofix US, LLC20230—
+6K223841KBA3DS.M.A.I.O20231—
+6K213272Formus HipFormus Labs, Ltd.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K222767PeekMed web (v1)Peek Health, S.A.20228—
+6K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+6K210344inVisionOSPrecisionos Technology, Inc.20210—
+6K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+6K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+6K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+6K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+6K210556Preview ShoulderGenesis Software Innovations20213—
+6K203651CuptimizeCuptimize, Inc.20213—
+6K200350MyHip Planner & VerifierMedacta International S.A.20201—
+6K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+6K193574Q-Rad SystemCarestream Health, Inc.20203—
+6K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+6K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+6K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+6K170172UNiD Spine AnalyzerMedicrea International20177—
+6K170195QuantXQuantitative Insights, Inc.20174—
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+6K163221Mazor XMazor Robotics, Ltd.201719—
+6K161479hipEOSOnefit Medical20169—
+6K160407spineEOSOnefit Medical20166—