510(k) Report

Devices descending from K110227

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131576Optima CT660Ge Medical Systems, LLC201358
+2K192686Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd.201945
+3K203169Revolution AscendGe Healthcare Japan Corporation202031
+4K213938Revolution AscendGe Healthcare Japan Corporation202222
+5K233698True Enhance DLGe Healthcare Japan Corporation20240—
+5K233749Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd.20240—