510(k) Report

Devices descending from K081496

10 later devices reach Optima Pet/CT 560 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133657Discovery Pet/CT 710Ge Medical Systems, LLC201474
+1K113408Q. Freeze (Motion VUE2)Ge Medical Systems, LLC20121—
+2K210418HYPER FocusShanghai United Imaging Healthcare Co., Ltd.20210—
+2K161574Discovery MIGe Medical Systems, LLC201653
+2K141477Discovery IQGe Medical Systems, LLC201403
+3K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)Raysolution Healthcare Co., Ltd.20250—
+3K211846Discovery MI Gen2Ge Medical Systems, LLC20213—
+4K221932Omni LegendGE Healthcare202221
+5K241665Omni LegendGe Medical Systems Israel, Functional Imaging202401
+5K223212Precision DLGE Healthcare20230—