510(k) Report

Devices descending from K080048

2 later devices reach MSK Extreme MR Scanner, Model AA5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1032381.5T Optima MR430SGe Medical Systems, LLC201112
+2K123068Optima MR 430SGe Medical Systems, LLC201202