510(k) Report

Devices descending from K942120

1,037 later devices reach Advantage Windows Diagnostic X-Ray Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K183037Monaco RTP SystemElekta, Inc.201856
+11K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+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—
+11K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+11K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+11K171754NovaPACSNovarad Corporation201741
+11K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+11K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+11K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+11K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+12K261210Cleerly PlaqueCleerly, Inc.20260—
+12K260588Cleerly LABSCleerly, Inc.20260—
+12K260528OncoStudioOncosoft. Inc.,20260—
+12K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+12K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+12K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+12K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+12K250696AccuCheckManteia Technologies Co., Ltd.20250—
+12K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+12K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K252539Tempus PixelArterys, Inc.20250—
+12K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+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—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+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—
+12K233457RUSHutom, Inc.20240—
+12K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+12K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+12K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+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—
+12K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+12K231662Aid-UIaid20241—
+12K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+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—
+12K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+12K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+12K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+12K221796Cyware 4H and Cysart 4HAbys Medical20221—
+12K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+12K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+12K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+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—
+12K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+12K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+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
+12K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+12K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+12K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+12K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+12K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+12K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+12K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+12K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+12K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+12K190178Monaco RTP SystemElekta, Inc.201945
+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
+12K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+12K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+13K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+13K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+13K252571mdprostateMediaire GmbH20260—
+13K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+13K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+13K253690LungMapsSiemens Healthineers AG20260—
+13K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+13K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+13K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+13K250039HPACSHealthhub20250—
+13K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+13K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K243069Lumys (V1)Intradys20250—
+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—
+13K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—