510(k) Report

Devices descending from K954355

758 later devices reach Advantage Windows 3D with Navigator Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+9K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+9K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K250039HPACSHealthhub20250—
+10K252539Tempus PixelArterys, Inc.20250—
+10K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+10K243069Lumys (V1)Intradys20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240791ADAS 3DAdas3D Medical S.L.20241—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K214036AVIEWCoreline Soft Co., Ltd.20224—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+10K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+10K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+10K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+10K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+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—
+11K252571mdprostateMediaire GmbH20260—
+11K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+11K253969ADAS 3DAdas3D Medical S.L.20260—
+11K253690LungMapsSiemens Healthineers AG20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+11K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+11K243689AVIEWCoreline Soft Co., Ltd.20250—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+11K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+11K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+11K233211Aview CacCoreline Soft Co., Ltd.20242—
+11K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+11K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+11K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+11K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+11K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+11K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+11K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+11K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+11K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+11K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+11K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+11K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+11K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—
+12K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+12K243696Aview CacCoreline Soft Co., Ltd.20250—
+12K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+12K241211CoLumboSmart Soft Healthcare20242—
+12K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+12K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—