510(k) Report

Devices descending from K921219

76 later devices reach Philips Dci-SX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971965Philips EasyvisionPhilips Medical Systems, Inc.199874—
+1K972103Philips EasyvisionPhilips Medical Systems North America, Inc.19970—
+2K081262DC NeuroInvivo Corporation20082—
+2K0508623TP Workspace3tp, LLC2005101
+2K041286Dynacad V1.0Mri Devices Corp.200417—
+2K0313503TP Software Option3tp, LLC2003191
+2K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp.2002489
+2K980831Image Post-Processing TechniquesPhilips Medical Systems (Cleveland), Inc.19980—
+3K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+3K173744ProFuse CADEigen20181—
+3K143397ICIS ViewAgfa Healthcare N.V.20156—
+3K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+3K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+3K113701Visia NeuroMeVis Medical Solutions AG20121—
+3K111945Impax Next GenerationAgfa Healthcare N.V.201122
+3K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+3K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K062878Ezpacs, Version 3.0Advanced Imaging Solutions, LLC20072—
+3K061421Erad PacsErad, Inc.200614—
+3K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+3K050228Agfa Heartlab CardiovascularHeartlab, Inc.2005922
+3K040896Modification to EncompassHeartlab, Inc.200411
+3K040344Impax OT3000 Orthopedic WorkstationAgfa Corp.20042—
+3K031132Consultiva Case Input Station, Model Cis-1Eastman Kodak Company20031—
+3K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+3K031638Cardio Vascular Information Enhanced WorkstationElectromed Imaging, Inc.20030—
+3K031248Consultiva Report Station, Model RS-1Miramedica, Inc.20031—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K231662Aid-UIaid20241—
+4K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+4K173312ProBx SoftwareHarmonus, Inc.20180—
+4K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+4K141329RadspaTelerad Tech Private Limited20140—
+4K132799Clariso PacsClariso, Inc.20134—
+4K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+4K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K061160M-VU Cad StationVucomp, Inc.20060—
+4K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc.200572
+4K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+4K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050—
+4K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041—
+5K250039HPACSHealthhub20250—
+5K241223eRAD PACSErad, Inc.20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K200822BraidBraid.Health20201—
+5K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+5K152977DG PacsDicom Grid, Inc.201641
+5K151957BOX DICOM ViewerBox, Inc.20153—
+5K111319Ibis Explorer and Markup SoftwareMedqia20116—
+5K060210MediportMaxant Technologies, Inc.20060—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+6K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+6K201296i-Rapha SolutionIrm, Inc.20200—
+6K180549ZED LinkZed Technologies20180—
+6K122205EXINIExini Diagnostics AB20125—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+7K231360Ambra PACSDicom Grid Dba Ambra Health202301
+7K191262aBSIExini Diagnostics AB20192—
+7K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+8K233998TRAQinform IQAiq Global, Inc.20240—
+8K211655aPROMISEExini Diagnostics AB20211—
+9K220590aPROMISE XExini Diagnostics AB20220—