510(k) Report

Devices descending from K063029

2 later devices reach Empower CT/Cta Injector System, Model 9800/9900 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc.20071—
+2K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.20260—