510(k) Report

Devices descending from K161574

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)Raysolution Healthcare Co., Ltd.20250—
+1K211846Discovery MI Gen2Ge Medical Systems, LLC20213—
+2K221932Omni LegendGE Healthcare202221
+3K241665Omni LegendGe Medical Systems Israel, Functional Imaging202401
+3K223212Precision DLGE Healthcare20230—