510(k) Report

Devices descending from K033326

214 later devices reach Philips Plus Computed Tomography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172135uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.2018127
+1K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.2016924
+1K153444Philips Multislice CT System with Low Dose CT Lung CancerPhilips Medical Systems (Cleveland), Inc.20161—
+1K151383NeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.201523
+1K071308Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.200717
+1K060937Brilliance VolumePhilips Medical Systems (Cleveland), Inc.20062461
+1K051351Precedence Spect/CT Imaging SystemAdac Laboratories200501
+1K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.20051312
+1K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041471
+2K230220NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20230—
+2K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+2K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2022317
+2K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202163
+2K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+2K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+2K192590CURA 778Fmi Medical Systems, Inc.20200—
+2K200016uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.202014
+2K181414uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.2018310
+2K180901Low Dose CT Lung Cancer Screening OptionHitachi Healthcare Americas20180—
+2K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.2018723
+2K171201NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.20170—
+2K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc.201716
+2K133603Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems20140—
+2K131773Brilliance IctPhilips Healthcare (Cleveland)201311—
+2K123576Imr Software ApplicationPhilips Healthcare (Cleveland)20130—
+2K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+2K113483Iterative Reconstruction Technique Software ApplicationPhilips Healthcare (Cleveland)20121—
+2K1125303DI Including CscoreShina Systems, Ltd.20111—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+2K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+2K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+2K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd.20080—
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+2K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+3K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+3K250648Philips iCT CT systemPhilips Medical Systems Nederland B.V.202503
+3K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd.202501
+3K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+3K240786AutoChamberHeartLung Corporation20241—
+3K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd.202415
+3K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202313
+3K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.20232—
+3K223311Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd.20220—
+3K210760Precise ImagePhilips Medical Systems Nederland B.V.20220—
+3K211168Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd.202111
+3K203514Precise PositionPhilips Healthcare (Suzhou) Co., Ltd.20210—
+3K183143uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd.20190—
+3K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland)2014106
+3K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+3K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K1134423DIShina Systems, Ltd.20120—
+3K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+3K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+3K0937033DIShina Systems, Ltd.20102—
+3K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+3K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.2008013
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.20260—
+4K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+4K252029AI-CVDHeartLung Corporation20250—
+4K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202503
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K172418OpenSightNovarad Corporation20185—
+4K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+4K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+4K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+4K170069AmCAD-UVAmcad Biomed Corporation20170—
+4K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc.201772
+4K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV201511
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K260169AV Cardiac CTPhilips Medical Systems Nederland B.V.20260—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K243884TavipilotCaranx Medical20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K231420Aura 10 PET/CTXeos Medical20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220146VisARNovarad Corporation20220—
+5K211764Vereos PET/CTPhilips Medical Systems Nederland B.V.20210—
+5K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241