510(k) Report

Devices descending from K020483

872 later devices reach Advantage Workstation 4.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+10K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+10K220039AutoSegAi Medic, Inc.20221—
+10K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+10K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+10K220727inHEART MODELSInheart, Sas20221—
+10K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+10K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+10K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+10K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+10K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+10K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K190178Monaco RTP SystemElekta, Inc.201945
+10K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+10K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+11K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+11K252571mdprostateMediaire GmbH20260—
+11K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+11K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+11K253690LungMapsSiemens Healthineers AG20260—
+11K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+11K253270Contour ProtégéAI+Mim Software, Inc.20260—
+11K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+11K250039HPACSHealthhub20250—
+11K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+11K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K243069Lumys (V1)Intradys20250—
+11K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+11K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+11K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+11K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+11K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+11K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+11K231683inHEART ModelsInheart, Sas20240—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+11K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+11K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+11K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+11K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+11K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+11K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+11K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+11K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+12K261306AI Contouring (VA10A)Varian Medical Systems20260—
+12K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+12K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K241211CoLumboSmart Soft Healthcare20242—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+12K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+12K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K220497CoLumboSmart Soft Healthcare AD20226—
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+12K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—