510(k) Report

Devices descending from K033400

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+9K202229AI MetricsAi Metrics, LLC20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+10K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+10K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+10K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+10K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+11K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+11K261306AI Contouring (VA10A)Varian Medical Systems20260—
+11K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+11K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+11K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+11K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+11K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+11K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+11K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+12K260748ES-SeriesE-Scopics20260—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K223233Monaco RTP SystemElekta Solutions AB20231—