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FDA 510(k)

BrainsWay Deep TMS System

K-Number: K251391 · 2025-11-07

ApplicantBrainsway , Ltd.
Decision Date2025-11-07
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BrainsWay Deep TMS System is the device name listed in this FDA 510(k) record. The listed applicant is Brainsway , Ltd.. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K251391. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BrainsWay Deep TMS System?

BrainsWay Deep TMS System is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Brainsway , Ltd.. The 510(k) number is K251391.

When did BrainsWay Deep TMS System receive FDA 510(k) clearance?

BrainsWay Deep TMS System received FDA 510(k) clearance on 2025-11-07, under 510(k) number K251391.

Who is the listed applicant for BrainsWay Deep TMS System?

The FDA 510(k) record lists Brainsway , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BrainsWay Deep TMS System?

The FDA product code for BrainsWay Deep TMS System is OBP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07216872Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)RECRUITINGNCT07706790Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) in Healthy AdultsCOMPLETEDNCT07770555Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use DisorderNOT_YET_RECRUITING

Other records listing Brainsway , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251449BrainsWay Deep TMS SystemK222196Deep TMS SystemK220819BrainsWay Deep TMS SystemK210201Deep Transcranial Magnetic Stimulation (DTMS) SystemK203735Brainsway Deep TMS SystemK203616Brainsway Deep (DTMS) System

View all 10 devices →

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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