510(k) Report

Devices descending from K183241

3 later devices reach BrainScope TBI (Model: Ahead 400) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190815BrainScope TBIBrainscope Company, Inc.20192—
+2K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.20231—
+3K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.20250—