510(k) Report

Devices descending from K981217

355 later devices reach Platinum Reading, Review & Analysis Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071492FirstviewRiverain Medical Group,Llc20070—
+1K063006GE Logiq WorksGeneral Electric Co.20060—
+1K023557Centricity Pacs PlusGE Medical Systems2002354—
+2K110797Communify Pacs ViewerFlying Squirrel Storage, LLC20111—
+2K043415Centricity Pacs SystemGe Medical Systems Information Technologies200532423
+2K043146Horizon Medical ImagingMckesson Medical Imaging Company20052711
+2K042292Isite PacsStentor, Inc.2004157
+2K031638Cardio Vascular Information Enhanced WorkstationElectromed Imaging, Inc.20030—
+3K152186HealthMyne PACSHealthmyne, Inc.20157—
+3K140909Mckesson RadiologyMckesson Medical Imaging Company201404
+3K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+3K120851Communify Pacs ViewerCommunify Health, LLC20130—
+3K112096ImagelinkComputer Programs and Systems, Inc.20110—
+3K110875Centricity PacsGE Healthcare2011610
+3K083018Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions200894
+3K081948Raypax SystemRaypax, Inc.20080—
+3K081976Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation200841
+3K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+3K070755InterworksAvreo, Inc.20071—
+3K063267Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co.200684
+3K062757Xeron PacsXeron Healthcare Corp.20060—
+3K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+3K053458WEB1000Agfa Corp.200552
+3K052618Imagecast PacsIdx Systems Corp.200502
+3K052460Powerserver, Powerreader, Gateway and PowercacheRamsoft, Inc.20050—
+3K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S20052—
+3K051649Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems20051017
+4K202700ART-PlanTherapanacea20215—
+4K192276Merge CardioMerge Healthcare Incorporated20190—
+4K190379MIM on LinuxMim Software, Inc.201914—
+4K182855ProKnow DSProknow, LLC20192—
+4K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+4K171544Arterys ViewerArterys, Inc.20176—
+4K141556Avreo Interworks SystemAvreo, Inc.20140—
+4K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+4K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+4K132342XVWEBApteryx, Inc.20133—
+4K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+4K111332Clarity Obp SystemElekta, Ltd.20122—
+4K112974Picture Archiving and Communications SystemCurve Dental, Inc.20117—
+4K111945Impax Next GenerationAgfa Healthcare N.V.201122
+4K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.201152
+4K110139Curve ImageCurve Dental, Inc.20110—
+4K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+4K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K083740Mammodiagnost VUPhilips Medical Systems Nederland B.V.20090—
+4K082706Infinitt Cardiology PacsInfinitt Co., Ltd.20080—
+4K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+4K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp.200701
+4K063392Imco-StatImco Technologies20061—
+4K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc.200572
+5K251880Archy Dental ImagingArchy Dental, Inc.20250—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K251363ProKnow DSElekta Solutions AB20250—
+5K233572AutofusePymedix20240—
+5K223800MIM – Additional TracersMim Software, Inc.20231—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K220813Art-PlanTherapanacea20224—
+5K220684Oryx Cloud ImagingOryx Dental Software, Inc.20220—
+5K220779XDMirada Medical, Ltd.20220—
+5K211257EFAI PACS Picture Archiving and Communication SystemEver Fortune.Ai, Co., Ltd.20211—
+5K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging20211—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+5K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc.20180—
+5K182815XVWeb 3DApteryx, Inc.20180—
+5K182034Arterys MICAArterys, Inc.20183—
+5K180522IGTFusionIgi Technologies20180—
+5K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+5K173636VelocityVarian Medical Systems, Inc.20188—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173420Radiomics App v1.0Microsoft Corp.20174—
+5K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K161130ResolutionMDCalgary Scientific, Inc.20164—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153014Mobius3DMobius Medical Systems, LP201613—
+5K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+5K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.20163—
+5K143514Panther StereoSeedProwess, Inc.20150—
+5K151438Dentrix Ascend ImagingRealcloud Imaging, Inc.20150—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K121663ClarityElekta, Ltd.20121—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K112480View 1 ImagingKarl Storz Endoscopy America, Inc.20110—
+5K111319Ibis Explorer and Markup SoftwareMedqia20116—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K260500ResolutionMDResolutionMD, Inc.20260—
+6K253111Aeka ImagingGood Methods Global, Inc.20260—
+6K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+6K232100Efai Pacs Picture Archiving and Communication System ProEver Fortune.Ai, Co., Ltd.20230—