Medical Device Manufacturer · IL , Kfar Saba

Brainsway , Ltd.

11 submissions · 11 cleared · Since 2013
11
Total
11
Cleared
0
Denied

Brainsway , Ltd. — FDA 510(k) Submissions

Brainsway , Ltd. has submitted 11 FDA 510(k) premarket notifications since 2013, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Transcranial Magnetic Stimulator, Transcranial Magnetic Stimulation System For Smoking Cessation, Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
BrainsWay Deep TMS System
K251391 · OBP Transcranial Magnetic... · Neurology
Nov 2025 186d
BrainsWay Deep TMS System
K251449 · OBP Transcranial Magnetic... · Neurology
Sep 2025 127d
Deep TMS System
K222196 · OBP Transcranial Magnetic... · Neurology
May 2024 679d
BrainsWay Deep TMS System
K220819 · OBP Transcranial Magnetic... · Neurology
Aug 2022 158d
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201 · OBP Transcranial Magnetic... · Neurology
Aug 2021 204d
Brainsway Deep TMS System
K203735 · OBP Transcranial Magnetic... · Neurology
Apr 2021 123d
Brainsway Deep (DTMS) System
K203616 · QMD Transcranial Magnetic... · Neurology
Apr 2021 127d
Brainsway Deep TMS System
K200957 · QMD Transcranial Magnetic... · Neurology
Aug 2020 134d
Brainsway Deep TMS System
K183303 · QCI Transcranial Magnetic... · Neurology
Mar 2019 101d
Brainsway Deep (DTMS) System
K173540 · OBP Transcranial Magnetic... · Neurology
May 2018 169d
BRAINSWAY DEEP TMS SYSTEM
K122288 · OBP Transcranial Magnetic... · Neurology
Jan 2013 161d
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