510(k) Report

Devices descending from K944331

1 later device reach Model 528GE Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, Inc.19970—