510(k) Report

Devices descending from K974367

355 later devices reach Advantx LCN, Advantx LCLP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K202229AI MetricsAi Metrics, LLC20200—
+11K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+11K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+11K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+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—
+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—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+13K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+14K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+14K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—
+14K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+15K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+15K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+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—
+15K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+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—