510(k) Report

Devices descending from K020546

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232479ART-PlanTherapanacea20232—
+7K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+7K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+7K203744Arterys MICAArterys, Inc.20221—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K200899Quantib AI NodeQuantib B.V.20200—
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K190868Cleerly LabsCleerly, Inc.20197—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+7K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+7K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+7K141329RadspaTelerad Tech Private Limited20140—
+7K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+7K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+7K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K252571mdprostateMediaire GmbH20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K260528OncoStudioOncosoft. Inc.,20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K252539Tempus PixelArterys, Inc.20250—
+8K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K240620Cube NavigatorMedical Templates AG20240—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+8K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+8K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+8K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K191530StoneCheckerImaging Biometrics, LLC20191—
+8K190764SurgicalARMedivis, Inc.20196—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K180867AmCAD-UOAmcad Biomed Corporation20180—
+8K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+8K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+9K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+9K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K230249IkshanaImmersivetouch20231—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202084DeepLook PRECISEDeeplook, Inc.20210—
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—