Medical Device Manufacturer · IL , Kfar Saba

Brainsway , Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2013

Recent clearances: BrainsWay Deep TMS System, BrainsWay Deep TMS System, Deep TMS System

11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Brainsway , Ltd. Neurology ✕

11 devices
1-11 of 11
Cleared Nov 07, 2025
BrainsWay Deep TMS System
K251391 · OBP
Neurology · 186d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449 · OBP
Neurology · 127d
Cleared May 31, 2024
Deep TMS System
K222196 · OBP
Neurology · 679d
Cleared CT Aug 26, 2022
BrainsWay Deep TMS System
K220819 · OBP
Neurology · 158d
Cleared Aug 17, 2021
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201 · OBP
Neurology · 204d
Cleared CT Apr 23, 2021
Brainsway Deep TMS System
K203735 · OBP
Neurology · 123d
Cleared Apr 16, 2021
Brainsway Deep (DTMS) System
K203616 · QMD
Neurology · 127d
Cleared Aug 21, 2020
Brainsway Deep TMS System
K200957 · QMD
Neurology · 134d
Cleared Mar 08, 2019
Brainsway Deep TMS System
K183303 · QCI
Neurology · 101d
Cleared May 03, 2018
Brainsway Deep (DTMS) System
K173540 · OBP
Neurology · 169d
Cleared Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
K122288 · OBP
Neurology · 161d
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