510(k) Report

Devices descending from K012009

263 later devices reach MX8000 Idt CT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091195Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511Philips Medical Systems (Cleveland), Inc.200918
+1K090173Neuviz 16 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200905
+1K083498Philips Model MX 16 Slice CT SystemPhilips Medical Systems (Cleveland), Inc.200805
+1K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041471
+1K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004652
+1K041218Griffin Spect/CT Imaging SystemAdac Laboratories2004111
+1K033677Brain Perfusion OptionPhilips Medical Systems (Cleveland), Inc.20043—
+1K033357Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc.20041050
+1K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc.2003214131
+1K032036Gemini 16Philips Medical Systems (Cleveland), Inc.2003872
+1K023785Lung Nodule Assessment and Comparison OptionPhilips Medical Systems (Cleveland), Inc.200310—
+2K191136Access CTPhilips Healthcare (Suzhou) Co., Ltd.20190—
+2K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+2K172135uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.2018127
+2K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc.2017614
+2K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+2K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.2016924
+2K160611P-ArtisP-Cure, Ltd.20161—
+2K153444Philips Multislice CT System with Low Dose CT Lung CancerPhilips Medical Systems (Cleveland), Inc.20161—
+2K151383NeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.201523
+2K133603Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems20140—
+2K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+2K1125303DI Including CscoreShina Systems, Ltd.20111—
+2K103720Synapse 3D Lung and Abdomen AnalysisFujifilm Medical Systems U.S.A, Inc.20110—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+2K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+2K071308Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200717
+2K070868LMS-Lung/TrackMedian Technologies20070—
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+2K060937Brilliance VolumePhilips Medical Systems (Cleveland), Inc.20062461
+2K051351Precedence Spect/CT Imaging SystemAdac Laboratories200501
+2K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+2K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+2K041182SyntegraAdac Laboratories200420—
+3K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.20260—
+3K250970MarieLeo Cancer Care20250—
+3K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+3K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd.20243—
+3K240786AutoChamberHeartLung Corporation20241—
+3K240740qCT LN QuantQure.Ai Technologies20240—
+3K230220NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20230—
+3K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+3K221612ClearRead CTRiverain Technologies, Inc.20220—
+3K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2022317
+3K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+3K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202163
+3K202990NinesMeasureNines, Inc.20211—
+3K201501VeolityMeVis Medical Solutions AG20210—
+3K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+3K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+3K193220Aview LCSCoreline Soft Co., Ltd.20201—
+3K192590CURA 778Fmi Medical Systems, Inc.20200—
+3K200016uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.202014
+3K181414uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.2018310
+3K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc.20181—
+3K180901Low Dose CT Lung Cancer Screening OptionHitachi Healthcare Americas20180—
+3K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2018723
+3K171201NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20170—
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc.201716
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K131773Brilliance IctPhilips Healthcare (Cleveland)201311—
+3K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+3K123576Imr Software ApplicationPhilips Healthcare (Cleveland)20130—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K113483Iterative Reconstruction Technique Software ApplicationPhilips Healthcare (Cleveland)20121—
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K1134423DIShina Systems, Ltd.20120—
+3K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+3K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+3K081987Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions20087—
+3K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+3K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd.20080—
+3K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+3K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd.20260—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K252029AI-CVDHeartLung Corporation20250—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K250648Philips iCT CT systemPhilips Medical Systems Nederland B.V.202503
+4K244008Spectral CTPhilips Medical Systems Technologies, Ltd.202503
+4K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd.202501
+4K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd.202415
+4K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202313
+4K231047UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions20230—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K230393UniCam Evo SoftwareInter Medical Medizintechnik GmbH20230—
+4K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.20232—
+4K223311Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd.20220—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K212875Spectral CT on RailsPhilips Medical Systems Nederland B.V.202206
+4K210760Precise ImagePhilips Medical Systems Nederland B.V.20220—
+4K211168Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd.202111
+4K203514Precise PositionPhilips Healthcare (Suzhou) Co., Ltd.20210—