510(k) Report

Devices descending from K071378

1 later device reach Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.20260—