Brainsway , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251391BrainsWay Deep TMS SystemNovember 7, 2025
K251449BrainsWay Deep TMS SystemSeptember 13, 2025
K222196Deep TMS SystemMay 31, 2024
K220819BrainsWay Deep TMS SystemAugust 26, 2022
K210201Deep Transcranial Magnetic Stimulation (DTMS) SystemAugust 17, 2021
K203735Brainsway Deep TMS SystemApril 23, 2021
K203616Brainsway Deep (DTMS) SystemApril 16, 2021
K200957Brainsway Deep TMS SystemAugust 21, 2020
K183303Brainsway Deep TMS SystemMarch 8, 2019
K173540Brainsway Deep (DTMS) SystemMay 3, 2018
K122288BRAINSWAY DEEP TMS SYSTEMJanuary 7, 2013