510(k) Report

Devices descending from K913770

1,148 later devices reach Advantage V.S. CT/MR Rad Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+11K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+11K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+11K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+11K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+11K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+11K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+12K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+12K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+12K250696AccuCheckManteia Technologies Co., Ltd.20250—
+12K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+12K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K240793MSKaiMskai20240—
+12K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+12K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+12K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+12K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+12K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+12K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+12K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+12K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+12K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+12K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+12K220039AutoSegAi Medic, Inc.20221—
+12K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+12K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+12K220727inHEART MODELSInheart, Sas20221—
+12K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+12K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+12K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+12K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+12K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+12K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+12K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+12K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+12K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+12K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+12K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+12K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+12K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+12K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+12K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+13K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+13K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+13K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+13K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+13K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+13K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+13K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+13K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+13K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+13K231683inHEART ModelsInheart, Sas20240—
+13K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+13K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+13K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+13K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+13K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+13K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+13K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+13K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+13K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+13K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+13K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+13K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+14K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+14K261306AI Contouring (VA10A)Varian Medical Systems20260—
+14K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+14K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+14K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+14K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+14K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+14K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+14K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+14K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+14K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+14K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+14K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+14K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+14K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+14K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+14K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241