510(k) Report

Devices descending from K963497

1 later device reach Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050963Gammacell 1000 Elite and Gammacell 3000 ElanMds Nordion20050—