510(k) Report

Devices descending from K004022

5 later devices reach M3 (Mirco-Multileaf Collimator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060187Topslane DMLCTopslane International, LLC20061—
+1K020860M3 (Micro-Multileaf Collimator)Brainlab AG200241
+2K090802Tigrt MLC, Tigrt DMLCLinatech, LLC20090—
+2K052705DART-12Direx Systems Corp.20061—
+3K071701Trackleaf-10Direx Systems Corp.20070—