510(k) Report

Devices descending from K040970

420 later devices reach Leonardo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K203744Arterys MICAArterys, Inc.20221—
+8K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201768Voluson E10GE Healthcare20204—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K190780syngo Application SoftwareSiemens Medical Solution USA, Inc.20197—
+8K190764SurgicalARMedivis, Inc.20196—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K260166Bunkerhill Contrast CACBunkerHill Health20260—
+9K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K250662Bunkerhill MACBunkerHill Health20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K251456BrightHeart View ClassifierBrightheart20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243229Bunkerhill AVCBunkerHill Health20253—
+9K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K230249IkshanaImmersivetouch20231—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K220433syngo Application Software (VE21)Siemens Medical Solution USA, Inc.20226—
+9K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+9K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K230955syngo Application SoftwareSiemens Medical Solutions USA, Inc.20235—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K250045uWS-Angio ProShanghai United Imaging Healthcare Co., Ltd.20250—
+11K250040uWS-AngioShanghai United Imaging Healthcare Co., Ltd.20250—
+11K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K241569syngo Application SoftwareSiemens Medical Solutions USA, Inc.20241—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—