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
+6K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+6K120472QuantraHologic, Inc.20123—
+6K113594C-THV SystemPaieon, Inc.20120—
+6K111332Clarity Obp SystemElekta, Ltd.20122—
+6K113076Caas a-ValvePie Medical Imaging BV20121—
+6K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+6K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+6K112974Picture Archiving and Communications SystemCurve Dental, Inc.20117—
+6K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+6K111319Ibis Explorer and Markup SoftwareMedqia20116—
+6K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+6K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.201152
+6K110139Curve ImageCurve Dental, Inc.20110—
+6K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+6K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+6K101842ACIESKonica Minolta Medical & Graphic, Inc.20113—
+6K103385Securview DX Diagnostic WorkstationHologic, Inc.201191
+6K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+6K102556Volpara, Version 1.3Matakina Technology Limited201024—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+6K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+6K082493Medical Display, MD205MG-1Nec Display Solutions, Ltd.20080—
+6K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+6K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.20084—
+6K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+6K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation20081—
+6K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd.20084—
+6K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+6K072532Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc.20070—
+6K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+6K071362Vital Connect 4.1Vital Images, Inc.2007113
+6K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+6K060210MediportMaxant Technologies, Inc.20060—
+6K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+7K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+7K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+7K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+7K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K251880Archy Dental ImagingArchy Dental, Inc.20250—
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K251363ProKnow DSElekta Solutions AB20250—
+7K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+7K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243703TechLiveDeepHealth, Inc.20250—
+7K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+7K243333rTOPRoclub GmbH20250—
+7K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+7K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+7K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+7K240740qCT LN QuantQure.Ai Technologies20240—
+7K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+7K233572AutofusePymedix20240—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+7K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—
+7K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+7K223800MIM – Additional TracersMim Software, Inc.20231—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K220256MIM-AblationMim Software, Inc.20224—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K220813Art-PlanTherapanacea20224—
+7K220684Oryx Cloud ImagingOryx Dental Software, Inc.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K220779XDMirada Medical, Ltd.20220—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K212421ADAS 3DAdas3D Medical S.L.20213—
+7K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging20211—
+7K202990NinesMeasureNines, Inc.20211—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+7K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+7K200323AutoContourRadformation, Inc.20207—
+7K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+7K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K201296i-Rapha SolutionIrm, Inc.20200—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K193220Aview LCSCoreline Soft Co., Ltd.20201—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—