510(k) Report

Devices descending from K052013

4 later devices reach Achieva 1.5T & Inera 1.5T Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131896Supervan 1.5T Magnetic Resonance Imaging SystemSuzhou Anke Medical System Co., Ltd.20140—
+1K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc.200823
+2K1032381.5T Optima MR430SGe Medical Systems, LLC201112
+3K123068Optima MR 430SGe Medical Systems, LLC201202