510(k) Report

Devices descending from K161068

6 later devices reach Ahead 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181179BrainScope OneBrainscope Company, Inc.20185—
+2K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc.20193—
+2K181785Modified BrainScope OneBrainscope Company, Inc.20180—
+3K190815BrainScope TBIBrainscope Company, Inc.20192—
+4K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.20231—
+5K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.20250—