510(k) Report

Devices descending from K211846

3 later devices reach Discovery MI Gen2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221932Omni LegendGE Healthcare202221
+2K241665Omni LegendGe Medical Systems Israel, Functional Imaging202401
+2K223212Precision DLGE Healthcare20230—