510(k) Report

Devices descending from K020483

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K243301MapRTVision Rt, Ltd.20250—
+9K250099Mobius3D (4.1)Varian Medical Systems20250—
+9K242925MR Contour DLGE Healthcare20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+9K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+9K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K223834AccuCheckManteia Technologies Co., Ltd.20231—
+9K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+9K203744Arterys MICAArterys, Inc.20221—
+9K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+9K212896Visible Patient SuiteVisible Patient, Sas20213—
+9K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+9K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+9K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+9K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+9K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+9K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+9K202084DeepLook PRECISEDeeplook, Inc.20210—
+9K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+9K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+9K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+9K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+9K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+9K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+9K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+9K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+9K171754NovaPACSNovarad Corporation201741
+9K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+9K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+10K261210Cleerly PlaqueCleerly, Inc.20260—
+10K260588Cleerly LABSCleerly, Inc.20260—
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K250696AccuCheckManteia Technologies Co., Ltd.20250—
+10K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+10K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K252539Tempus PixelArterys, Inc.20250—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+10K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+10K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+10K233457RUSHutom, Inc.20240—
+10K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K231662Aid-UIaid20241—
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+10K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K221796Cyware 4H and Cysart 4HAbys Medical20221—
+10K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—