510(k) Report

Devices descending from K983256

477 later devices reach Advantage Windows (AW) Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K150738VitreaViewVital Images, Inc.20158—
+7K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+7K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+7K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+7K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+7K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+7K121934Tomotherapy Treatment SystemAccuray Incorporated2012108
+7K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+7K121023Spectrum V.0Intrinsic Medical Imaging20120—
+7K120207VISIAMeVis Medical Solutions AG20120—
+7K120484Visia OncologyMeVis Medical Solutions AG20128—
+7K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+7K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+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
+8K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K260528OncoStudioOncosoft. Inc.,20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252029AI-CVDHeartLung Corporation20250—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K252539Tempus PixelArterys, Inc.20250—
+8K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+8K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K190978RefleXion Medical Radiotherapy SystemReflexion Medical, Inc.202001
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K190868Cleerly LabsCleerly, Inc.20197—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K183012vascuCAPElucid Bioimaging, Inc.20182—
+8K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+8K171837TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated201701
+8K163232Vitrea ViewVital Images, Inc.20177—
+8K161136Precision Treatment Planning SystemAccuray Incorporated20162—
+8K161146Radixact Treatment Delivery SystemAccuray Incorporated201631
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+8K152488Onrad Treatment SystemAccuray Incorporated20150—
+8K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+8K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+8K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+8K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+8K141329RadspaTelerad Tech Private Limited20140—
+8K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+8K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+8K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K240620Cube NavigatorMedical Templates AG20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—