510(k) Report

Devices descending from K192686

4 later devices reach Revolution Maxima, Revolution Ace through their predicates, nearest generation first.

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