510(k) Report

Devices descending from K923077

518 later devices reach Advantage Windows 3D Option and Dentascan Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+5K211180Liver SuiteGE Medical Systems SCS20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+5K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K201798myQA iONIba Dosimetry GmbH202011
+5K200274CariCloudCaristo Diagnostics20200—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192277CardIQ FlowGE Medical Systems SCS20200—
+5K190868Cleerly LabsCleerly, Inc.20197—
+5K191610RTappSegana, LLC20191—
+5K191761Mobius3DVarian Medical Systems, Inc.20195—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K182966PLANET Onco DoseDosisoft20191—
+5K182855ProKnow DSProknow, LLC20192—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K171350Collision CheckRadformation, Inc.20174—
+5K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+5K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+5K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+5K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+5K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+5K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+5K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+5K130228SuiteheartNeosoft, LLC20130—
+5K113620Myrian 1.11Intrasense20126—
+5K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+5K120484Visia OncologyMeVis Medical Solutions AG20128—
+5K113543ONDEMAND3DCybermed, Inc.20119—
+5K113541Clearstart SVM SystemIntio, Inc.201171
+5K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+5K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+5K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+5K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+5K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+5K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+5K071241LMS-LiverMedian Technologies20079—
+6K260597Virtue QAProNova Solutions20260—
+6K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+6K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+6K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+6K252029AI-CVDHeartLung Corporation20250—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+6K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+6K233660nCommand Lite SystemIonic Health20240—
+6K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+6K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K220779XDMirada Medical, Ltd.20220—
+6K212887RTappSegana, Inc.20210—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K200899Quantib AI NodeQuantib B.V.20200—
+6K200179Collaboration LivePhilips Health Care20204—
+6K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+6K191125ADAS 3DGalgo Medical S.L20205—
+6K192424Mobius3DVarian Medical Systems, Inc.20194—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+6K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K163253Arterys Cardio DLArterys, Inc.20174—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K162513Arterys Software v2.0Arterys, Inc.20165—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K162112Caas MRVPie Medical Imaging BV20162—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+6K160088Cydar EVCydar, Ltd.20167—