510(k) Report

Devices descending from K063090

6 later devices reach Medrad Stellant CT Injector System with XDS Accessory through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201841
+1K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+2K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201831
+3K210541ulrichINJECT CT motionUlrich GmbH & Co. KG20211—
+3K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc.201901
+4K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG20250—