510(k) Report

Devices descending from K033400

637 later devices reach Seno Advantage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+6K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K261465Indira Cloud ViewerIndigo Technologies20260—
+7K253884Koios DS (3.8)Koios Medical, Inc.20260—
+7K261519Sonio SuspectSonio20260—
+7K253078ART.1-USSeetreat Pty, Ltd.20260—
+7K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+7K252922Neosoma Brain MetsNeosoma, Inc.20250—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K252294Fetal EchoScan (v1.2)Brightheart20250—
+7K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250484PIUR tUS insidePiur Imaging GmbH20250—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K251071Fetal EchoScan (v1.1)Brightheart20251—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K241837Limbus ContourLimbus Ai, Inc.20240—
+7K241561MammoScreen BDTherapixel20241—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K233634TeleScanBb Imaging20230—
+7K231185MapRTVision Rt, Ltd.20231—
+7K230082Auto SegmentationGe Medical Systems, LLC20231—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K221706AccuContourManteia Technologies Co., Ltd.20232—
+7K220630TorchTM SoftwareVoximetry, Incorporated20221—
+7K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K213628VBrainVysioneer, Inc.20210—
+7K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+7K212116VBrain-OARVysioneer, Inc.20211—
+7K2116563D Echo v1.1Jointvue, LLC20210—
+7K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K203669Mobius3DVarian Medical Systems, Inc.20213—
+7K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+7K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+7K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+7K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+7K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+7K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—