510(k) Report

Devices descending from K011447

244 later devices reach IN Space 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+9K243696Aview CacCoreline Soft Co., Ltd.20250—
+9K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+10K250367CoLumboXSmart Soft Healthcare AD20250—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+10K240793MSKaiMskai20240—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+11K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+11K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+11K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+12K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+13K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+14K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+14K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+14K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+15K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+15K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+16K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+17K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—