510(k) Report

Devices descending from K012009

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201710A View LCSCoreline Soft Co., Ltd.20200—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K183143uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd.20190—
+4K172418OpenSightNovarad Corporation20185—
+4K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.201703
+4K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+4K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+4K170069AmCAD-UVAmcad Biomed Corporation20170—
+4K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+4K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland)2014106
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation201422
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)201345
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+4K0937033DIShina Systems, Ltd.20102—
+4K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+4K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.20080—
+4K071241LMS-LiverMedian Technologies20079—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+5K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K243884TavipilotCaranx Medical20250—
+5K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202503
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220146VisARNovarad Corporation20220—
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K210880Vereos PET/CTPhilips Medical Systems Nederland B.V.20212—
+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
+5K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+5K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+5K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+5K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+5K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+5K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+5K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+5K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation20171—
+5K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc.201772
+5K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV201511
+5K121213VitreaadvancedVital Images, Inc.201281
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K260748ES-SeriesE-Scopics20260—
+6K260169AV Cardiac CTPhilips Medical Systems Nederland B.V.20260—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K250120GECHONarnar, LLC20250—
+6K243069Lumys (V1)Intradys20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K231420Aura 10 PET/CTXeos Medical20230—
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+6K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K211764Vereos PET/CTPhilips Medical Systems Nederland B.V.20210—
+6K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+6K193454IQon Spectral CTPhilips Medical Systems Nederland B.V.202066
+6K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+6K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K181646Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation20180—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+7K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+7K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+7K212012Follicle ClarityCycle Clarity20221—
+7K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+7K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+7K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+7K203020Spectral CTPhilips Medical Systems Nederland B.V.202158
+7K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+7K2013523D Auto LAAPhilips Health Care20200—