510(k) Report

Devices descending from K020546

442 later devices reach Fusion 7D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+5K091001Myrian 1.4Intrasense20097—
+5K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+5K071362Vital Connect 4.1Vital Images, Inc.2007113
+5K071331Vitrea Version 4.0Vital Images, Inc.2007821
+5K071000MyrianIntrasense20078—
+5K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+5K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K251355X1-FFRSpectrawave, Inc.20250—
+6K250039HPACSHealthhub20250—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K243069Lumys (V1)Intradys20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K240786AutoChamberHeartLung Corporation20241—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K233457RUSHutom, Inc.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K232147CAAS WorkstationPie Medical Imaging BV20241—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K233080HealthFLDNano-X AI, Ltd.20240—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K201710A View LCSCoreline Soft Co., Ltd.20200—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K200822BraidBraid.Health20201—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163668SuitestensaEbit Srl20170—
+6K163071vascuCAPElucid Bioimaging, Inc.20173—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K150738VitreaViewVital Images, Inc.20158—
+6K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+6K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+6K121023Spectrum V.0Intrinsic Medical Imaging20120—
+6K120207VISIAMeVis Medical Solutions AG20120—
+6K120484Visia OncologyMeVis Medical Solutions AG20128—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+6K083691BonevueMicromri, Inc.20090—
+6K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+6K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+6K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+6K072821Vitrea 4DCTVital Images, Inc.2008171
+7K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K243769QFR (3.0)Qfr Solutions BV20250—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—