510(k) Report

Devices descending from K040970

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+6K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+6K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+6K182034Arterys MICAArterys, Inc.20183—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+6K170747syngo Application SoftwareSiemens Medical Solutions USA, Inc.20179—
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K150738VitreaViewVital Images, Inc.20158—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K131158CorviewMarrek, Inc.20130—
+6K121916IntuitionTerarecon,Inc.201351
+6K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+6K120282CardnavPaieon, Inc.20120—
+6K120514CardiopacsLumedx20120—
+7K260192DIANAROPCA ApS20260—
+7K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+7K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+7K242359Strain AI (SAI001)Exo, Inc.20240—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+7K234141AISAP Cardio V1.0Aisap20240—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K232501AI Platform (AIP001)Exo, Inc.20231—
+7K230209Sonix HealthOntact Health Co., Ltd.20233—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+7K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+7K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+7K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K200274CariCloudCaristo Diagnostics20200—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K173611syngo Application SoftwareSiemens Medical Solutions USA, Inc.20188—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+8K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+8K252007BlineSlideDeep Breathe, Inc.20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243684BrightHeart View ClassifierBrightheart20251—
+8K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+8K233457RUSHutom, Inc.20240—
+8K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.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—
+8K230112CAC SoftwareImbio, Inc.20230—
+8K230223iCAC DeviceBunkerhill, Inc.20236—