510(k) Report

Devices descending from K013381

470 later devices reach Advanced Lung Analysis-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233457RUSHutom, Inc.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K230023ART-PlanTherapanacea Sas20233—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K210670BU-CADTaihao Medical, Inc.20213—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192277CardIQ FlowGE Medical Systems SCS20200—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K190764SurgicalARMedivis, Inc.20196—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+7K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+7K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+8K260086CadAI-B DxBeamWorks, Inc.20260—
+8K261210Cleerly PlaqueCleerly, Inc.20260—
+8K260588Cleerly LABSCleerly, Inc.20260—
+8K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+8K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232479ART-PlanTherapanacea20232—
+8K230249IkshanaImmersivetouch20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K203744Arterys MICAArterys, Inc.20221—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—