510(k) Report

Devices descending from K982862

463 later devices reach Radworks Medical Imaging Software with Quality Control Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083618Pacs ScanPacsgear, Inc.20091—
+1K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Ge Medical Systems Information Technologies2004223
+1K030363Org@Nizer, Model Version 3.0Ebit Sanita, S.P.A.20030—
+1K012779Iconnection 3DHinnovation, Inc.200131—
+1K012093Aetmed Image Processing SoftwareAetmed, S.P.A.200164—
+1K012211Efilm WorkstationEfilm Medical, Inc.20013331
+1K993761Cardiovascular Measurement System - ViewMedis Medical Imaging Systems BV19996—
+2K151687QuantorView3Disc Americas20150—
+2K141061Remoteye ViewerNeologica S.R.L.20141—
+2K140869DCAS IGp&P Co., Ltd.20140—
+2K131392Etiam Pacs ComponentsEtiam S.A.S.U.20130—
+2K112807X-Ray VvaMedis Medical Imaging Systems BV20122—
+2K103181Zenis, Picture Archiving and Communications SystemGenoray Co., Ltd.20110—
+2K092235Beyondimage WorkstationNeusoft Medical Systems Co., Ltd.20091—
+2K071894Xebra Dicom Image BrowserHx Technologies, Inc.20072—
+2K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions2006183
+2K063006GE Logiq WorksGeneral Electric Co.20060—
+2K052411Hipax Medical Imaging SoftwareSteinhart Medizinsysteme GmbH200580—
+2K041326Medcommons Open Radiology GatewayMedcommons, Inc.20040—
+2K041581Compacs, Version 1.0Intelligent Images Srl20041—
+2K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+2K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB20042—
+2K023476Unipacs WorkstationUniversal Pacs, Inc.200312—
+2K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc.200261—
+2K020995Efilm Workstation with ModulesEfilm Medical, Inc.20023212
+3K242166TribusConnectTribusmed Beheer BV20250—
+3K222036MPXA-2000Medipixel, Inc.20231—
+3K140797Ipacs Medical Image Management SystemVisbion Limited20140—
+3K142423EyeSuite ImagingHaag-Streit AG201421
+3K120514CardiopacsLumedx20120—
+3K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+3K110129Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC20115—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K110006Ois Symphony Image Managment SystemOphthalmic Imaging Systems201104
+3K103679Axis Pacs, HMS PacsAxis Health Care, LLC20110—
+3K102435Beyondimage WorkstationNeusoft Medical Systems Co., Ltd.20100—
+3K102000ImagysKeosys Sas20103—
+3K093313SynergyTopcon Medical Systems, Inc.200929—
+3K090266MatchedflickerEyeic Corporation20090—
+3K090439FORUMCarl Zeiss Meditec, Inc.200932—
+3K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+3K082706Infinitt Cardiology PacsInfinitt Co., Ltd.20080—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Topcon Corp.200850—
+3K081630Mammo WorkstationImage Diagnost International GmbH20084—
+3K081304Alz Web Pacs, Version 1.0Alz, Inc.20088—
+3K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+3K072960CDP 5000, Media and Distribution Center, DiagnetCdp, Ltd.200702
+3K070618Dicompacs, Model 5Oehm Und Rehbein GmbH200778—
+3K063539Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS200775—
+3K062229CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc.20060—
+3K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+3K062154Vital Connect 4.0Vital Images, Inc.2006124
+3K051745EchosystemMedstrat, Inc.20050—
+3K051127Kika Imaging Lab Viewer, Model 2.0.1.0Kika Medical, Inc.20050—
+3K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd.200412—
+3K042700Image Medical Acquisition Station (Imas)Erad Imagemedical Corp.20040—
+3K042781Ipacs CardioRealtimeimage, Inc.20041—
+3K041162Ortho-CMSMedis Medical Imaging Systems BV20042—
+3K032401OrthoviewOmsbar, Ltd.2003133—
+4K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+4K200275OVision Imaging SystemOphthalmic Labs, Inc.20200—
+4K171098AXIS Image Management SystemSonomed, Inc.20171—
+4K161829Huvitz Imaging SystemHuvitz Co., Ltd.20171—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K133022ZedviewLexi Co., Ltd.201410—
+4K133476Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG20144—
+4K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+4K132667Synergy OdmTopcon Medical Systems, Inc.20139—
+4K130624CONIGlobalmed20137—
+4K130453ExcelsiorEyekor, LLC20131—
+4K123575MammoworkstationImage Diagnost International GmbH20132—
+4K120282CardnavPaieon, Inc.20120—
+4K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG2012251
+4K113696Optos AdvanceOptos Plc.20124—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K113855Panorad, Panorad SLImix Adr Finland OY20120—
+4K103554Metron-CP/MDEponatech, LLC20110—
+4K110869CARADiagnos, Inc.201101
+4K110040OmnivisionModern Module, Inc.201115—
+4K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated201013—
+4K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+4K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+4K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+4K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH200958—
+4K083491NeuroscapeOlea Medical20090—
+4K082441Nordicice SoftwareNordicimaginglab AS2008732
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K063327OrthoviewMerdian Technique, Ltd.200613—
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+4K042816Traumacad 1.2Orthocrat, Ltd.2004129—
+4K042383Rsa-CMSMedis Medical Imaging Systems BV20041—
+5K220929ExcelsiorMerit Cro, Inc.20220—
+5K213527FORUMCarl Zeiss Meditec, AG20221—
+5K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+5K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG20210—
+5K211655aPROMISEExini Diagnostics AB20211—