510(k) Report

Devices descending from K941546

297 later devices reach Somatom Project 059 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+5K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.20051236
+6K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+6K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd.20260—
+6K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K252029AI-CVDHeartLung Corporation20250—
+6K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+6K250648Philips iCT CT systemPhilips Medical Systems Nederland B.V.202503
+6K244008Spectral CTPhilips Medical Systems Technologies, Ltd.202503
+6K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung20251—
+6K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd.202501
+6K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+6K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+6K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd.202415
+6K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202313
+6K231047UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions20230—
+6K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung20233—
+6K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+6K230393UniCam Evo SoftwareInter Medical Medizintechnik GmbH20230—
+6K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.20232—
+6K223311Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd.20220—
+6K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+6K212875Spectral CT on RailsPhilips Medical Systems Nederland B.V.202206
+6K213278Planmed VerityPlanmed OY20220—
+6K210760Precise ImagePhilips Medical Systems Nederland B.V.20220—
+6K211168Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd.202111
+6K203514Precise PositionPhilips Healthcare (Suzhou) Co., Ltd.20210—
+6K201710A View LCSCoreline Soft Co., Ltd.20200—
+6K190868Cleerly LabsCleerly, Inc.20197—
+6K183143uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd.20190—
+6K172418OpenSightNovarad Corporation20185—
+6K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC201805
+6K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+6K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+6K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+6K170069AmCAD-UVAmcad Biomed Corporation20170—
+6K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+6K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland)2014106
+6K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+6K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+6K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+6K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+6K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+6K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+6K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+6K0937033DIShina Systems, Ltd.20102—
+6K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+6K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+6K071241LMS-LiverMedian Technologies20079—
+7K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.20260—
+7K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+7K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+7K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+7K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+7K243884TavipilotCaranx Medical20250—
+7K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202503
+7K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+7K233767OmniTom EliteNeurologica Corporation20242—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+7K220146VisARNovarad Corporation20220—
+7K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+7K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+7K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+7K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+7K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+7K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+7K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+7K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+7K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+7K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+7K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+7K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+7K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc.201772
+7K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV201511
+7K121213VitreaadvancedVital Images, Inc.201281
+8K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+8K260748ES-SeriesE-Scopics20260—
+8K260169AV Cardiac CTPhilips Medical Systems Nederland B.V.20260—
+8K250928OmniTom Elite with PCDNeurologica Corporation20250—
+8K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+8K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+8K250120GECHONarnar, LLC20250—
+8K243069Lumys (V1)Intradys20250—
+8K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+8K232189OrionXRHoth Intelligence, Inc.20230—
+8K231420Aura 10 PET/CTXeos Medical20230—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+8K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—