510(k) Report

Devices descending from K131576

5 later devices reach Optima CT660 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192686Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd.201945
+2K203169Revolution AscendGe Healthcare Japan Corporation202031
+3K213938Revolution AscendGe Healthcare Japan Corporation202222
+4K233698True Enhance DLGe Healthcare Japan Corporation20240—
+4K233749Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd.20240—