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Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

DEN170078 Class II Direct
Decision Date
2018-08-17
Sponsor / Applicant
Brainways , Ltd.

Technical Specification

510(k) Submission ID DEN170078
Product Code QCI
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5802
Decision Date 2018-08-17
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System received FDA 510(k) clearance under submission number DEN170078, sponsored by Brainways , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-08-17.

Classification & Regulation

This clearance is catalogued under FDA product code QCI and 21 CFR 882.5802, within the Neurology review panel as a Class II device.