510(k) Report

Devices descending from K003408

378 later devices reach CT Cord IQ Option 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212915MVision AI SegmentationMVision AI20221—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+8K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K193252Contour ProtegeAIMim Software, Inc.20206—
+8K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K182034Arterys MICAArterys, Inc.20183—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+8K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+8K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K260166Bunkerhill Contrast CACBunkerHill Health20260—
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K250662Bunkerhill MACBunkerHill Health20250—
+9K250039HPACSHealthhub20250—
+9K243069Lumys (V1)Intradys20250—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K243229Bunkerhill AVCBunkerHill Health20253—
+9K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K231683inHEART ModelsInheart, Sas20240—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K223424Spine Auto ViewsGE Medical Systems SCS20230—
+9K230023ART-PlanTherapanacea Sas20233—
+9K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K213944HealthOSTNanoxai, Ltd.20221—
+9K210632Contour ProtegeAIMim Software, Inc.20215—
+9K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+9K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+9K192437Arterys MICAArterys, Inc.20202—
+9K192277CardIQ FlowGE Medical Systems SCS20200—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+9K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K163668SuitestensaEbit Srl20170—
+9K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+9K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+9K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+9K151233MonacoImpac Medical Systems, Inc.201569
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+10K252362GBrain MRIGalileo Cds, Inc.20250—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+10K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+10K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+10K233080HealthFLDNano-X AI, Ltd.20240—
+10K232479ART-PlanTherapanacea20232—
+10K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+10K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+10K203744Arterys MICAArterys, Inc.20221—
+10K213976Contour ProtégéAIMim Software, Inc.20224—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K201948AcroDTI VisualizerAcroviz, Inc.20200—