FDA.reportPublic FDA data

510(k) K251449

Device
BrainsWay Deep TMS System
Applicant
Brainsway , Ltd.
510(k) number
K251449
Product code
OBP
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-13
Date received
2025-05-09
Regulation
882.5805
Classification name
Transcranial Magnetic Stimulator
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Colleen Hanlon
Address
16 Hartom St. (Bynat Bldg) Har Hotzvim Jerusalem IL 9777518 9777518

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.2026-09-06
K260691BTL-699BTL Industries, Inc.2026-08-23
K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.2026-08-14
K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S2026-05-22
K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH2026-05-22
K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj2026-03-20
K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj2026-03-20
K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.2026-02-20
K251391BrainsWay Deep TMS SystemBrainsway , Ltd.2025-11-07
K250689CloudTMS EdgeTeleemg, LLC2025-09-14
K243700Apollo TMS Therapy SystemMag & More GmbH2025-09-04
K243539Apollo TMS Therapy SystemMag & More GmbH2025-08-18
K251125MagVenture TMS Therapy SystemTonica Elektronik A/S2025-08-11
K251119MagVenture TMS Therapy SystemTonica Elektronik A/S2025-08-08
K252032T65 (9016E061-)Tonica Elektronik A/S2025-07-30