510(k) Report

Devices descending from K020995

321 later devices reach Efilm Workstation with Modules through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140797Ipacs Medical Image Management SystemVisbion Limited20140—
+1K103679Axis Pacs, HMS PacsAxis Health Care, LLC20110—
+1K102000ImagysKeosys Sas20103—
+1K082135ShowcaseTrillium Technology, Inc.20080—
+1K081304Alz Web Pacs, Version 1.0Alz, Inc.20088—
+1K072960CDP 5000, Media and Distribution Center, DiagnetCdp, Ltd.200702
+1K070618Dicompacs, Model 5Oehm Und Rehbein GmbH200778—
+1K063539Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS200775—
+1K051745EchosystemMedstrat, Inc.20050—
+1K051127Kika Imaging Lab Viewer, Model 2.0.1.0Kika Medical, Inc.20050—
+1K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd.200412—
+1K042700Image Medical Acquisition Station (Imas)Erad Imagemedical Corp.20040—
+1K041326Medcommons Open Radiology GatewayMedcommons, Inc.20040—
+1K041162Ortho-CMSMedis Medical Imaging Systems BV20042—
+1K032401OrthoviewOmsbar, Ltd.2003133—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K133022ZedviewLexi Co., Ltd.201410—
+2K130624CONIGlobalmed20137—
+2K113855Panorad, Panorad SLImix Adr Finland OY20120—
+2K103554Metron-CP/MDEponatech, LLC20110—
+2K110040OmnivisionModern Module, Inc.201115—
+2K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+2K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH200958—
+2K083491NeuroscapeOlea Medical20090—
+2K082441Nordicice SoftwareNordicimaginglab AS2008732
+2K063327OrthoviewMerdian Technique, Ltd.200613—
+2K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+2K042816Traumacad 1.2Orthocrat, Ltd.2004129—
+2K042383Rsa-CMSMedis Medical Imaging Systems BV20041—
+3K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+3K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG20210—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K200704ZedViewLexi Co., Ltd.20210—
+3K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+3K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+3K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+3K160284JointPointJointpoint, Inc.201621—
+3K153653DICOM ViewerBrainlab AG20164—
+3K150725Visaris AvanseVisaris D.O.O. Belgrade20151—
+3K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+3K133966Model-Based Rsa SoftwareHalifax Biomedical, Inc.20140—
+3K132763Advanced ViewerBrainlab AG20141—
+3K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+3K110033Feel-DRCSImfou Co., Ltd.201116—
+3K102078Radiological Image Processing SystemVATECH Co., Ltd.20116—
+3K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+3K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+3K090546Modification to Nordicice SoftwareNordicimaginglab AS200972—
+3K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+3K073271OrthogonAgfa Healthcare Corporation20070—
+4K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+4K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+4K231225EConsole1DRTECH Corporation20233—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K212720nordicDSCNordicneurolab AS20222—
+4K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+4K203651CuptimizeCuptimize, Inc.20213—
+4K200350MyHip Planner & VerifierMedacta International S.A.20201—
+4K202519OrthoNext Platform SystemOrthofix Srl20201—
+4K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K191014Elements ViewerBrainlab AG20203—
+4K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+4K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185—
+4K182464PeekMedPeek Health, S.A.201817—
+4K173329jFit Surgical PlannerJointvue, LLC20170—
+4K163324nordicBrainExNordicneurolab AS20175—
+4K161937CuattroDRCuattro, LLC201601
+4K161828kneeEOSOnefit Medical20162—
+4K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+4K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.20165—
+4K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+4K152172Econsole1DRTECH Corporation20156—
+4K142930Exam Vue DRJpi Healthcare Co, Ltd.20151—
+4K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+4K142671Onefit Hip PlannerOnefit Medical201410—
+4K141669SurgimapNemaris, Inc.201427—
+4K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+4K141199Quentry Dose ReviewBrainlab AG20140—
+4K140434Medicad ClassicHectec GmbH20140—
+4K133910NordicbrainexNordicneurolab201452
+4K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+4K130278MR PermeabilityPhilips Medical Systems Nederland B.V.20131—
+4K123306Nordic TumorexNordicneurolab201301
+4K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+4K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+4K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+4K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20132—
+4K123302IB ClinicImaging Biometrics, LLC20131—
+4K120196Olea SphereOlea Medical201251—
+4K120115OrthosizeOrthosize, LLC201201
+4K111161Perfscape V2.0Olea Medical201153—
+4K111019Surgimap (TM) SpineNemaris, Inc.201151—
+4K092102Nordicbrainex Software, Version 1.0Nordicimaginglab AS200901
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+5K261861SPINEsim v1.0Mdsim S.A.20260—
+5K2613522D Hip Planning SoftwareOne Ortho20260—