510(k) Report

Devices descending from K091373

200 later devices reach Syngo Trued through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130393Mirada RTXMirada Medical, Ltd.201336—
+1K102687Mirada RTMirada Medical, Ltd.201037—
+1K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+1K101228Mirada XDMirada Medical, Ltd.201070—
+1K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+2K220779XDMirada Medical, Ltd.20220—
+2K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+2K202700ART-PlanTherapanacea20215—
+2K200323AutoContourRadformation, Inc.20207—
+2K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+2K181572Workflow BoxMirada Medical, Ltd.201825—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K173542Arterys Oncology DLArterys, Inc.20185—
+2K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+2K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+2K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+2K161201ClearRead CTRiverain Technologies, LLC20165—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+2K133521Aze Phoenix SoftwareAze, Ltd.20140—
+2K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+2K123920Syngo.ViaSiemens AG Medical Solutions201363—
+2K113620Myrian 1.11Intrasense20126—
+2K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+2K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+2K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+2K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+3K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+3K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+3K242919V5med Lung AIV5med, Inc.20250—
+3K221612ClearRead CTRiverain Technologies, Inc.20220—
+3K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+3K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+3K220813Art-PlanTherapanacea20224—
+3K212915MVision AI SegmentationMVision AI20221—
+3K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+3K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+3K210831OnQ NeuroCortechs Labs, Inc.20213—
+3K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+3K202928DV. TargetDeepvoxel, Inc.20210—
+3K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+3K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+3K193252Contour ProtegeAIMim Software, Inc.20206—
+3K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+3K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+3K182034Arterys MICAArterys, Inc.20183—
+3K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+3K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+3K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+3K150843syngo®.via (version VB10A)Siemens AG201546—
+3K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+4K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+4K250416GBrain MRIGalileo Cds, Inc.20251—
+4K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+4K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+4K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+4K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+4K230023ART-PlanTherapanacea Sas20233—
+4K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+4K210632Contour ProtegeAIMim Software, Inc.20215—
+4K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+4K192437Arterys MICAArterys, Inc.20202—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+4K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+4K190232Synapse PACSFujifilm Corporation2019311
+4K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+4K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+4K173475Merge PACSMerge Healthcare Incorporated201712
+4K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+4K163668SuitestensaEbit Srl20170—
+4K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+4K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+4K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+5K252362GBrain MRIGalileo Cds, Inc.20250—
+5K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+5K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+5K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+5K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+5K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+5K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+5K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+5K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+5K232479ART-PlanTherapanacea20232—