510(k) Report

Devices descending from K012211

333 later devices reach Efilm Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151687QuantorView3Disc Americas20150—
+1K141061Remoteye ViewerNeologica S.R.L.20141—
+1K092235Beyondimage WorkstationNeusoft Medical Systems Co., Ltd.20091—
+1K071894Xebra Dicom Image BrowserHx Technologies, Inc.20072—
+1K052411Hipax Medical Imaging SoftwareSteinhart Medizinsysteme GmbH200580—
+1K041326Medcommons Open Radiology GatewayMedcommons, Inc.20040—
+1K023476Unipacs WorkstationUniversal Pacs, Inc.200312—
+1K020995Efilm Workstation with ModulesEfilm Medical, Inc.20023212
+2K242166TribusConnectTribusmed Beheer BV20250—
+2K140797Ipacs Medical Image Management SystemVisbion Limited20140—
+2K103679Axis Pacs, HMS PacsAxis Health Care, LLC20110—
+2K102435Beyondimage WorkstationNeusoft Medical Systems Co., Ltd.20100—
+2K102000ImagysKeosys Sas20103—
+2K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K081304Alz Web Pacs, Version 1.0Alz, Inc.20088—
+2K072960CDP 5000, Media and Distribution Center, DiagnetCdp, Ltd.200702
+2K070618Dicompacs, Model 5Oehm Und Rehbein GmbH200778—
+2K063539Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS200775—
+2K062229CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc.20060—
+2K051745EchosystemMedstrat, Inc.20050—
+2K051127Kika Imaging Lab Viewer, Model 2.0.1.0Kika Medical, Inc.20050—
+2K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd.200412—
+2K042700Image Medical Acquisition Station (Imas)Erad Imagemedical Corp.20040—
+2K041162Ortho-CMSMedis Medical Imaging Systems BV20042—
+2K032401OrthoviewOmsbar, Ltd.2003133—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K133022ZedviewLexi Co., Ltd.201410—
+3K130624CONIGlobalmed20137—
+3K113855Panorad, Panorad SLImix Adr Finland OY20120—
+3K103554Metron-CP/MDEponatech, LLC20110—
+3K110040OmnivisionModern Module, Inc.201115—
+3K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+3K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+3K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH200958—
+3K083491NeuroscapeOlea Medical20090—
+3K082441Nordicice SoftwareNordicimaginglab AS2008732
+3K063327OrthoviewMerdian Technique, Ltd.200613—
+3K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K042816Traumacad 1.2Orthocrat, Ltd.2004129—
+3K042383Rsa-CMSMedis Medical Imaging Systems BV20041—
+4K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+4K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG20210—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K200704ZedViewLexi Co., Ltd.20210—
+4K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+4K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+4K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+4K160284JointPointJointpoint, Inc.201621—
+4K153653DICOM ViewerBrainlab AG20164—
+4K150725Visaris AvanseVisaris D.O.O. Belgrade20151—
+4K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+4K133966Model-Based Rsa SoftwareHalifax Biomedical, Inc.20140—
+4K132763Advanced ViewerBrainlab AG20141—
+4K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+4K110033Feel-DRCSImfou Co., Ltd.201116—
+4K102078Radiological Image Processing SystemVATECH Co., Ltd.20116—
+4K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+4K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+4K090546Modification to Nordicice SoftwareNordicimaginglab AS200972—
+4K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+4K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+4K073271OrthogonAgfa Healthcare Corporation20070—
+5K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+5K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+5K231225EConsole1DRTECH Corporation20233—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K212720nordicDSCNordicneurolab AS20222—
+5K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+5K203651CuptimizeCuptimize, Inc.20213—
+5K200350MyHip Planner & VerifierMedacta International S.A.20201—
+5K202519OrthoNext Platform SystemOrthofix Srl20201—
+5K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K191014Elements ViewerBrainlab AG20203—
+5K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+5K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185—
+5K182464PeekMedPeek Health, S.A.201817—
+5K173329jFit Surgical PlannerJointvue, LLC20170—
+5K163324nordicBrainExNordicneurolab AS20175—
+5K161937CuattroDRCuattro, LLC201601
+5K161828kneeEOSOnefit Medical20162—
+5K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+5K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.20165—
+5K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+5K152172Econsole1DRTECH Corporation20156—
+5K142930Exam Vue DRJpi Healthcare Co, Ltd.20151—
+5K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+5K142671Onefit Hip PlannerOnefit Medical201410—
+5K141669SurgimapNemaris, Inc.201427—
+5K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+5K141199Quentry Dose ReviewBrainlab AG20140—
+5K140434Medicad ClassicHectec GmbH20140—
+5K133910NordicbrainexNordicneurolab201452
+5K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+5K130278MR PermeabilityPhilips Medical Systems Nederland B.V.20131—
+5K123306Nordic TumorexNordicneurolab201301
+5K124051The Vault SystemSomersault Orthopedics, Inc.20131—