510(k) Report

Devices descending from K160153

2 later devices reach ABL90 Flex Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+1K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—