510(k) Report

Devices descending from K012950

9 later devices reach Modification to: Medrad Spectris Solaris MR Injector System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033247Medrad Spectris Solaris MR Injector SystemMedrad, Inc.20037—
+1K031483Medrad Manual Syringe LoaderMedrad, Inc.20030—
+2K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc.20161—
+2K042784Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc.20044—
+3K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+3K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBayer Medical Care, Inc.201521
+3K091734Sonic Shot GXNemoto Kyorindo Co., Ltd.20100—
+4K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitBayer Medical Care, Inc.20181—
+5K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…Bayer Medical Care, Inc.20260—