510(k) Report

Devices descending from K103476

5 later devices reach BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142383Optima XR200amx, Optima XR220amxGe Medical Systems, LLC201448
+2K162990Optima XR240amxGe Medical Systems, LLC201632
+3K173602Optima XR240amx, AutoGridGe Medical Systems, LLC201822
+4K182234Optima XR240amxGe Medical Systems, LLC201812
+5K210982AMX NavigateGe Medical Systems, LLC202101