Cleared Traditional

Brainsway Deep TMS System

K183303 · Brainsway , Ltd. · Neurology

Mar 2019

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K183303 is an FDA 510(k) clearance for the Brainsway Deep TMS System, a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI), submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on March 8, 2019, 101 days after receiving the submission on November 27, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number	K183303 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2018
Decision Date	March 08, 2019
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QCI — Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5802
Definition	External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).