510(k) Report

Devices descending from K952291

2 later devices reach Gammacell 3000 Elan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963497Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Nordion International, Inc.19961—
+2K050963Gammacell 1000 Elite and Gammacell 3000 ElanMds Nordion20050—