510(k) Report

Devices descending from K940606

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+7K250648Philips iCT CT systemPhilips Medical Systems Nederland B.V.202503
+7K244008Spectral CTPhilips Medical Systems Technologies, Ltd.202503
+7K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd.202501
+7K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+7K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+7K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd.202415
+7K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202313
+7K231047UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions20230—
+7K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20233—
+7K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+7K230393UniCam Evo SoftwareInter Medical Medizintechnik GmbH20230—
+7K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.20232—
+7K223311Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd.20220—
+7K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K212875Spectral CT on RailsPhilips Medical Systems Nederland B.V.202206
+7K210760Precise ImagePhilips Medical Systems Nederland B.V.20220—
+7K211168Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd.202111
+7K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.20214—
+7K203514Precise PositionPhilips Healthcare (Suzhou) Co., Ltd.20210—
+7K201710A View LCSCoreline Soft Co., Ltd.20200—
+7K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc.2019162
+7K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.201915—
+7K190868Cleerly LabsCleerly, Inc.20197—
+7K183143uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd.20190—
+7K172418OpenSightNovarad Corporation20185—
+7K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+7K170069AmCAD-UVAmcad Biomed Corporation20170—
+7K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+7K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland)2014106
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+7K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+7K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+7K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+7K0937033DIShina Systems, Ltd.20102—
+7K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+7K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+7K071241LMS-LiverMedian Technologies20079—
+8K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+8K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+8K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+8K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+8K243884TavipilotCaranx Medical20250—
+8K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202503
+8K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+8K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.20242—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+8K220814NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc.202231
+8K220146VisARNovarad Corporation20220—
+8K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+8K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+8K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+8K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+8K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+8K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+8K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+8K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+8K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+8K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc.2020147
+8K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+8K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+8K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+8K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+8K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc.201772
+8K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV201511
+8K121213VitreaadvancedVital Images, Inc.201281
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K260748ES-SeriesE-Scopics20260—
+9K260169AV Cardiac CTPhilips Medical Systems Nederland B.V.20260—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K250120GECHONarnar, LLC20250—
+9K243069Lumys (V1)Intradys20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.20251—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+9K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+9K232189OrionXRHoth Intelligence, Inc.20230—
+9K231420Aura 10 PET/CTXeos Medical20230—
+9K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+9K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+9K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+9K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+9K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+9K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+9K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…Siemens Medical Solutions USA, Inc.2021123