510(k) Report

Devices descending from K190815

2 later devices reach BrainScope TBI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.20231—
+2K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.20250—