Cleared Traditional

K183303 - Brainsway Deep TMS System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183303 · Brainsway , Ltd. · Neurology device
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Mar 2019
Decision
101d
Days
Class 2
Risk

K183303 is an FDA 510(k) clearance for the Brainsway Deep TMS System. Classified as Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (product code QCI), Class II - Special Controls.

Submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on March 8, 2019 after a review of 101 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainsway , Ltd. devices

Submission Details

510(k) Number K183303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 148d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 8
Devices cleared under the same product code (QCI) and FDA review panel - the closest regulatory comparables to K183303.
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