510(k) Report

Devices descending from K143538

2 later devices reach MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc.20181—
+2K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…Bayer Medical Care, Inc.20260—