Not Cleared Direct

Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (DEN170078) - FDA 510(k) Clearance

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170078 · Brainways , Ltd. · Neurology device
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Aug 2018
Decision
322d
Days
Class 2
Risk

DEN170078 is an FDA 510(k) submission (not cleared) for the Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System. Classified as Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (product code QCI), Class II - Special Controls.

Submitted by Brainways , Ltd. (Har Hotzvim, IL). The FDA issued a Not Cleared (DENG) decision on August 17, 2018 after a review of 322 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5802 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 322 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Brainways , Ltd. devices

Submission Details

510(k) Number DEN170078 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2017
Decision Date August 17, 2018
Days to Decision 322 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 148d · This submission: 322d
Pathway characteristics

Device Classification

Product Code QCI Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QCI Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder

All 9
Devices cleared under the same product code (QCI) and FDA review panel - the closest regulatory comparables to DEN170078.
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