510(k) Report

Devices descending from K052995

113 later devices reach Advantage Workstation 4.3. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110834AW Volumeshare 5 with Angioviz OptionGE Healthcare2011131
+1K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS200965—
+1K091001Myrian 1.4Intrasense20097—
+1K090552UrocareNeusoft Medical Systems Co., Ltd.20090—
+1K081985AW ServerGe Medical Systems, LLC2008275
+1K071000MyrianIntrasense20078—
+1K061587Fullcard AnalysisGE Healthcare20061—
+1K060453Aze VirtualplaceAze, Ltd.20061—
+2K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+2K210830VUZE SystemVuze Medical, Ltd.20221—
+2K192277CardIQ FlowGE Medical Systems SCS20200—
+2K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+2K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+2K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+2K133521Aze Phoenix SoftwareAze, Ltd.20140—
+2K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+2K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+2K130069Innova Epvision 2.0, Innova Epvision 2.0GE Healthcare20130—
+2K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+2K113620Myrian 1.11Intrasense20126—
+2K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+2K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K232976VUZE SystemVuze Medical, Ltd.20240—
+3K233660nCommand Lite SystemIonic Health20240—
+3K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+3K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+3K200899Quantib AI NodeQuantib B.V.20200—
+3K200179Collaboration LivePhilips Health Care20204—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+3K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+3K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+3K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+3K142647mint LesionMint Medical GmbH201523
+3K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+4K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+4K243703TechLiveDeepHealth, Inc.20250—
+4K243333rTOPRoclub GmbH20250—
+4K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+4K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+4K220929ExcelsiorMerit Cro, Inc.20220—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K202229AI MetricsAi Metrics, LLC20200—
+4K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+4K160088Cydar EVCydar, Ltd.20167—
+4K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K243884TavipilotCaranx Medical20250—
+5K222998F3Acrew Imaging, Inc.20230—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+5K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+5K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+5K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+5K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K171829EndoNautTherenva Sas20173—
+6K252500CARA SystemCara Medical, Ltd.20260—
+6K241302SonoSyncSamsung Medison Co., Ltd.20240—
+6K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+6K212383EndoNautTherenva Sas20212—
+6K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+7K222070EndoNautTherenva Sas20221—
+7K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+8K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—