510(k) Report

Devices descending from K913770

1,148 later devices reach Advantage V.S. CT/MR Rad Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+8K251484CT:VQ4Dmedical Limited20250—
+8K243884TavipilotCaranx Medical20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+8K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+8K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+8K232514MIM – Dose AnalysisMim Software, Inc.20240—
+8K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K222998F3Acrew Imaging, Inc.20230—
+8K230112CAC SoftwareImbio, Inc.20230—
+8K231360Ambra PACSDicom Grid Dba Ambra Health202301
+8K230803ADAS 3DAdas3D Medical S.L.20232—
+8K230223iCAC DeviceBunkerhill, Inc.20236—
+8K230023ART-PlanTherapanacea Sas20233—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K212915MVision AI SegmentationMVision AI20221—
+8K203744Arterys MICAArterys, Inc.20221—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K212616Koios DSKoios Medical, Inc.20214—
+8K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+8K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+8K203785ClariSIGMAMClaripi, Inc.20210—
+8K203555AmCAD-UTAmcad Biomed Corporation20212—
+8K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+8K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+8K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+8K210066ImagePilotKonica Minolta, Inc.202111
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K201411Visage Breast DensityVisage Imaging GmbH20210—
+8K201555EchoGo ProUltromics, Ltd.20206—
+8K201710A View LCSCoreline Soft Co., Ltd.20200—
+8K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201232Limbus ContourLimbus Ai, Inc.20202—
+8K201798myQA iONIba Dosimetry GmbH202011
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+8K192973densitas densityaiDensitas, Inc.20205—
+8K191610RTappSegana, LLC20191—
+8K191262aBSIExini Diagnostics AB20192—
+8K191761Mobius3DVarian Medical Systems, Inc.20195—
+8K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+8K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K182966PLANET Onco DoseDosisoft20191—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K182624MIM - MRT DosimetryMim Software, Inc.201853—
+8K182016Simplicit90YMirada Medical, Ltd.20183—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+8K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+8K182230Multi Modality ViewerVital Images, Inc.20180—
+8K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+8K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+8K173574DenSeeMammoStatlife20180—
+8K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+8K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+8K180019CAAS WorkstationPie Medical Imaging BV20188—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+8K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+8K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd.20182—
+8K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+8K171350Collision CheckRadformation, Inc.20174—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+8K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+8K163623QuantraHologic, Inc.20170—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+8K171829EndoNautTherenva Sas20173—
+8K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+8K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+8K163232Vitrea ViewVital Images, Inc.20177—
+8K163071vascuCAPElucid Bioimaging, Inc.20173—
+8K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+8K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+8K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—