510(k) Report

Devices descending from K052029

296 later devices reach Syngo Circulation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K182034Arterys MICAArterys, Inc.20183—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192277CardIQ FlowGE Medical Systems SCS20200—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163668SuitestensaEbit Srl20170—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K142647mint LesionMint Medical GmbH201523
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—