510(k) Report

Devices descending from K974715

298 later devices reach Advantage 3D XR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+8K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+8K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+8K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K233457RUSHutom, Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K214036AVIEWCoreline Soft Co., Ltd.20224—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+9K211655aPROMISEExini Diagnostics AB20211—
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K243689AVIEWCoreline Soft Co., Ltd.20250—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K233211Aview CacCoreline Soft Co., Ltd.20242—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220590aPROMISE XExini Diagnostics AB20220—
+10K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+10K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+10K142647mint LesionMint Medical GmbH201523
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+11K243696Aview CacCoreline Soft Co., Ltd.20250—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+11K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+11K241211CoLumboSmart Soft Healthcare20242—
+11K220929ExcelsiorMerit Cro, Inc.20220—
+11K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K202229AI MetricsAi Metrics, LLC20200—
+11K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+11K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+11K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+12K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+13K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+16K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+16K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+17K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+17K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+18K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+19K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—