510(k) Report

Devices descending from K945512

525 later devices reach HRSW Option for CT Twin Flash through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982060Volumax CT Imaging SystemElscint, Inc.1998264—
+1K974344CT ScopeElscint, Inc.19980—
+1K970980Cardiac Scoring for CT ScannersElscint, Inc.1997276—
+1K964583XRT-7.0Elscint, Inc.19970—
+2K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200126361
+2K990442Advanced Diagnostic Viewer (Aox), Model Vitred 1.3Vital Images, Inc.19990—
+2K982004CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage WindowsGeneral Electric Co.1998274—
+3K091195Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511Philips Medical Systems (Cleveland), Inc.200918
+3K090173Neuviz 16 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200905
+3K083498Philips Model MX 16 Slice CT SystemPhilips Medical Systems (Cleveland), Inc.200805
+3K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041471
+3K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004652
+3K041218Griffin Spect/CT Imaging SystemAdac Laboratories2004111
+3K033677Brain Perfusion OptionPhilips Medical Systems (Cleveland), Inc.20043—
+3K033357Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc.20041050
+3K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc.2003214131
+3K032036Gemini 16Philips Medical Systems (Cleveland), Inc.2003872
+3K023785Lung Nodule Assessment and Comparison OptionPhilips Medical Systems (Cleveland), Inc.200310—
+3K020929Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems2002272—
+3K013146Viatronic V3D Calcium ScoringViatronix, Inc.20011—
+4K213725CardIQ SuiteGE Medical Systems SCS20224—
+4K191136Access CTPhilips Healthcare (Suzhou) Co., Ltd.20190—
+4K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+4K172135uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.2018127
+4K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc.2017614
+4K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+4K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.2016924
+4K160611P-ArtisP-Cure, Ltd.20161—
+4K153444Philips Multislice CT System with Low Dose CT Lung CancerPhilips Medical Systems (Cleveland), Inc.20161—
+4K151383NeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.201523
+4K133603Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems20140—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K1125303DI Including CscoreShina Systems, Ltd.20111—
+4K103720Synapse 3D Lung and Abdomen AnalysisFujifilm Medical Systems U.S.A, Inc.20110—
+4K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+4K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+4K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+4K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C200745—
+4K071308Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200717
+4K070868LMS-Lung/TrackMedian Technologies20070—
+4K062650EP Navigator SoftwarePhilips Medical Systems200649—
+4K060937Brilliance VolumePhilips Medical Systems (Cleveland), Inc.20062461
+4K051351Precedence Spect/CT Imaging SystemAdac Laboratories200501
+4K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+4K050033LucionMevisys Co., Ltd.20053—
+4K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+4K041182SyntegraAdac Laboratories200420—
+4K032823Medicheart, Model Release 1Medicsight20030—
+4K022919Smart Breath Respiratory Compensation OptionGE Medical Systems2002217—
+5K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.20260—
+5K252217CT VScore+Canon Medical Informatics, Inc.20250—
+5K250970MarieLeo Cancer Care20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd.20243—
+5K240786AutoChamberHeartLung Corporation20241—
+5K240740qCT LN QuantQure.Ai Technologies20240—
+5K233731CardIQ SuiteGE Medical Systems SCS20242—
+5K230220NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20230—
+5K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2022317
+5K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+5K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202163
+5K202990NinesMeasureNines, Inc.20211—
+5K201501VeolityMeVis Medical Solutions AG20210—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+5K193220Aview LCSCoreline Soft Co., Ltd.20201—
+5K192590CURA 778Fmi Medical Systems, Inc.20200—
+5K200016uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.202014
+5K181414uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.2018310
+5K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc.20181—
+5K172983HealthCCSZebra Medical Vision, Ltd.201814—
+5K180901Low Dose CT Lung Cancer Screening OptionHitachi Healthcare Americas20180—
+5K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2018723
+5K171201NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20170—
+5K163622Lung VisionBodyvision Medical, Ltd.20176—
+5K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc.201716
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+5K131773Brilliance IctPhilips Healthcare (Cleveland)201311—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K123576Imr Software ApplicationPhilips Healthcare (Cleveland)20130—
+5K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+5K113483Iterative Reconstruction Technique Software ApplicationPhilips Healthcare (Cleveland)20121—
+5K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+5K1134423DIShina Systems, Ltd.20120—
+5K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+5K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+5K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+5K081987Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions20087—
+5K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+5K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd.20080—
+5K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+5K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+5K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+5K032915Advantage 4D OptionGe Medical Systems, LLC2003216—
+6K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+6K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd.20260—