510(k) Report

Devices descending from K010336

494 later devices reach Advantage Windows CT/Pet Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K260528OncoStudioOncosoft. Inc.,20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K253078ART.1-USSeetreat Pty, Ltd.20260—
+7K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+7K250696AccuCheckManteia Technologies Co., Ltd.20250—
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K250039HPACSHealthhub20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K231683inHEART ModelsInheart, Sas20240—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K201710A View LCSCoreline Soft Co., Ltd.20200—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K200822BraidBraid.Health20201—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K192437Arterys MICAArterys, Inc.20202—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K163071vascuCAPElucid Bioimaging, Inc.20173—
+7K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+7K150738VitreaViewVital Images, Inc.20158—
+7K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+7K121023Spectrum V.0Intrinsic Medical Imaging20120—
+7K120207VISIAMeVis Medical Solutions AG20120—
+7K120484Visia OncologyMeVis Medical Solutions AG20128—
+7K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+7K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+7K083691BonevueMicromri, Inc.20090—
+7K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+7K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+7K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+7K072821Vitrea 4DCTVital Images, Inc.2008171
+8K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K203744Arterys MICAArterys, Inc.20221—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—