510(k) Report

Devices descending from K940606

300 later devices reach Hispeed Advantage II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc.1999312
+1K973168Smartview Options for Hispeed CT/IGE Medical Systems19971—
+1K964747Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc.1997265—
+1K964746Hispeed CT/I with Performix Tube and Warp Scan OptionGE Medical Systems19973—
+1K961055CT Prospeed CT/IGE Medical Systems19960—
+2K153429SmartView 3D OptionGe Hangwei Medical System Co., Ltd.20160—
+2K042328Somatom SpiritSiemens Medical Systems, Inc.2004302
+2K012238DoserightPhilips Medical Systems North America Co.20010—
+2K982060Volumax CT Imaging SystemElscint, Inc.1998264—
+3K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc.2014292
+3K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200126361
+4K151749somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT…Siemens Medical Solutions USA, Inc.201602
+4K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20152716
+4K091195Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511Philips Medical Systems (Cleveland), Inc.200918
+4K090173Neuviz 16 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200905
+4K083498Philips Model MX 16 Slice CT SystemPhilips Medical Systems (Cleveland), Inc.200805
+4K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041471
+4K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004652
+4K041218Griffin Spect/CT Imaging SystemAdac Laboratories2004111
+4K033677Brain Perfusion OptionPhilips Medical Systems (Cleveland), Inc.20043—
+4K033357Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc.20041050
+4K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc.2003214131
+4K032036Gemini 16Philips Medical Systems (Cleveland), Inc.2003872
+4K023785Lung Nodule Assessment and Comparison OptionPhilips Medical Systems (Cleveland), Inc.200310—
+5K191136Access CTPhilips Healthcare (Suzhou) Co., Ltd.20190—
+5K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+5K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.2018204
+5K172135uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.2018127
+5K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc.20170—
+5K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc.2017614
+5K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc.2017196
+5K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+5K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.2016211
+5K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.2016244
+5K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.2016924
+5K160611P-ArtisP-Cure, Ltd.20161—
+5K153444Philips Multislice CT System with Low Dose CT Lung CancerPhilips Medical Systems (Cleveland), Inc.20161—
+5K151383NeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.201523
+5K133603Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems20140—
+5K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+5K1125303DI Including CscoreShina Systems, Ltd.20111—
+5K103720Synapse 3D Lung and Abdomen AnalysisFujifilm Medical Systems U.S.A, Inc.20110—
+5K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+5K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+5K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+5K071308Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200717
+5K070868LMS-Lung/TrackMedian Technologies20070—
+5K062650EP Navigator SoftwarePhilips Medical Systems200649—
+5K060937Brilliance VolumePhilips Medical Systems (Cleveland), Inc.20062461
+5K051351Precedence Spect/CT Imaging SystemAdac Laboratories200501
+5K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+5K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.2004142
+5K041182SyntegraAdac Laboratories200420—
+6K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.20260—
+6K250970MarieLeo Cancer Care20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd.20243—
+6K240786AutoChamberHeartLung Corporation20241—
+6K240740qCT LN QuantQure.Ai Technologies20240—
+6K230220NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20230—
+6K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2022317
+6K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+6K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202163
+6K202990NinesMeasureNines, Inc.20211—
+6K201501VeolityMeVis Medical Solutions AG20210—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+6K193220Aview LCSCoreline Soft Co., Ltd.20201—
+6K192590CURA 778Fmi Medical Systems, Inc.20200—
+6K200016uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.202014
+6K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.20191913
+6K181414uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.2018310
+6K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc.20181—
+6K180901Low Dose CT Lung Cancer Screening OptionHitachi Healthcare Americas20180—
+6K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc.20181818
+6K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2018723
+6K171201NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20170—
+6K163622Lung VisionBodyvision Medical, Ltd.20176—
+6K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc.201716
+6K163297Scan&GOSiemens Medical Solutions USA, Inc.201719—
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K131773Brilliance IctPhilips Healthcare (Cleveland)201311—
+6K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+6K123576Imr Software ApplicationPhilips Healthcare (Cleveland)20130—
+6K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+6K113483Iterative Reconstruction Technique Software ApplicationPhilips Healthcare (Cleveland)20121—
+6K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+6K1134423DIShina Systems, Ltd.20120—
+6K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+6K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+6K081987Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions20087—
+6K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+6K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd.20080—
+6K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+6K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+7K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—