510(k) Report

Devices descending from K010336

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K183012vascuCAPElucid Bioimaging, Inc.20182—
+8K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+8K163232Vitrea ViewVital Images, Inc.20177—
+8K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+8K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+8K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+8K141329RadspaTelerad Tech Private Limited20140—
+8K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+8K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K240620Cube NavigatorMedical Templates AG20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, 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—
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K191530StoneCheckerImaging Biometrics, LLC20191—
+9K190764SurgicalARMedivis, Inc.20196—
+9K180867AmCAD-UOAmcad Biomed Corporation20180—
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K244012Mosaic (V1.0.1)Navier Medical20250—
+10K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K230249IkshanaImmersivetouch20231—
+10K221870CarnaLife HoloMedapp S.A.20230—
+10K213215VSI HoloMedicineApoqlar GmbH20222—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202084DeepLook PRECISEDeeplook, Inc.20210—
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+11K251577Laia XRAugmented Reality Software S.L.20260—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K240793MSKaiMskai20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K240094LumiNE US; LumiAugmedit B.V.20240—
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+13K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+14K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+14K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+14K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+15K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+15K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+16K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+17K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—