510(k) Report

Devices descending from K984634

245 later devices reach 3D-Angio through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+10K243696Aview CacCoreline Soft Co., Ltd.20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K240793MSKaiMskai20240—
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+12K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—
+13K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+13K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+14K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+14K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+14K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+14K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+15K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+15K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+15K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+16K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+16K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+17K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+18K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—