510(k) Report

Devices descending from K181179

5 later devices reach BrainScope One through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc.20193—
+1K181785Modified BrainScope OneBrainscope Company, Inc.20180—
+2K190815BrainScope TBIBrainscope Company, Inc.20192—
+3K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.20231—
+4K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.20250—