510(k) Report

Devices descending from K051840

113 later devices reach Ensite Verismo Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101697Ensite Verismo Segmentation Tool V.2.0St Jude Medical201029—
+1K071331Vitrea Version 4.0Vital Images, Inc.2007821
+2K163071vascuCAPElucid Bioimaging, Inc.20173—
+2K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical201628—
+2K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+2K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+2K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+2K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K121213VitreaadvancedVital Images, Inc.201281
+2K121023Spectrum V.0Intrinsic Medical Imaging20120—
+2K120207VISIAMeVis Medical Solutions AG20120—
+2K120484Visia OncologyMeVis Medical Solutions AG20128—
+2K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+2K083691BonevueMicromri, Inc.20090—
+2K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+2K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+2K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+2K072821Vitrea 4DCTVital Images, Inc.2008171
+3K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+3K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+3K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+3K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+3K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+3K190868Cleerly LabsCleerly, Inc.20197—
+3K183012vascuCAPElucid Bioimaging, Inc.20182—
+3K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+3K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+3K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical201827—
+3K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+3K153289HealthmyneHealthmyne, Inc.20160—
+3K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+3K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+3K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+3K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+3K132853NovapacsNovarad Corp.201462
+3K141329RadspaTelerad Tech Private Limited20140—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+4K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+4K240620Cube NavigatorMedical Templates AG20240—
+4K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+4K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K191530StoneCheckerImaging Biometrics, LLC20191—
+4K180867AmCAD-UOAmcad Biomed Corporation20180—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201826—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K160371NovaPACSNovarad Corporation20165—
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+5K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K244012Mosaic (V1.0.1)Navier Medical20250—
+5K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201825—
+5K171754NovaPACSNovarad Corporation201741
+6K261210Cleerly PlaqueCleerly, Inc.20260—
+6K260588Cleerly LABSCleerly, Inc.20260—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K233457RUSHutom, Inc.20240—
+6K231662Aid-UIaid20241—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220727inHEART MODELSInheart, Sas20221—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical202018—
+6K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…Abbott Medical20205—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K250039HPACSHealthhub20250—
+7K243069Lumys (V1)Intradys20250—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+7K231683inHEART ModelsInheart, Sas20240—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+8K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+8K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+8K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+8K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K212061EnSite X EP SystemAbbott202113—
+9K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+9K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+9K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K213364EnSite X EP SystemAbbott Medical202112—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—