510(k) Report

Devices descending from K220819

2 later devices reach BrainsWay Deep TMS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243319Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20251—
+2K251210Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20250—