Cleared Traditional

Brainsway Deep (DTMS) System

K173540 · Brainsway , Ltd. · Neurology
May 2018
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K173540 is an FDA 510(k) clearance for the Brainsway Deep (DTMS) System, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on May 3, 2018, 169 days after receiving the submission on November 15, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K173540 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2017
Decision Date May 03, 2018
Days to Decision 169 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.