510(k) Report

Devices descending from K110834

13 later devices reach AW Volumeshare 5 with Angioviz Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151212Ziostation2Qi Imaging, LLC20152—
+1K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+1K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+2K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+2K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+4K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+5K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+6K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+7K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—