510(k) Report

Devices descending from K180515

3 later devices reach GammaTile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190296GammaTileGt Medical Technologies20192—
+2K190839GammaTileGt Medical Technologies20201—
+3K221539GammaTileGt Medical Technologies20220—