510(k) Report

Devices descending from K163281

2 later devices reach FastStroke through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193289FastStroke, CT Perfusion 4DGE Medical Systems SCS20201—
+2K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—