510(k) Report

Devices descending from K161162

4 later devices reach Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192856MT OneM&T S.R.L.20202—
+1K180406Ellipse YdunEllipse A/S20180—
+2K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—