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FDA 510(k)

Brainsway Deep (DTMS) System

K-Number: K203616 · 2021-04-16

ApplicantBrainsway , Ltd.
Decision Date2021-04-16
Product CodeQMD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Brainsway Deep (DTMS) System is the device name listed in this FDA 510(k) record. The listed applicant is Brainsway , Ltd.. It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K203616. The device is classified under product code QMD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainsway Deep (DTMS) System?

Brainsway Deep (DTMS) System is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Brainsway , Ltd.. The 510(k) number is K203616.

When did Brainsway Deep (DTMS) System receive FDA 510(k) clearance?

Brainsway Deep (DTMS) System received FDA 510(k) clearance on 2021-04-16, under 510(k) number K203616.

Who is the listed applicant for Brainsway Deep (DTMS) System?

The FDA 510(k) record lists Brainsway , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brainsway Deep (DTMS) System?

The FDA product code for Brainsway Deep (DTMS) System is QMD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07216872Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)RECRUITINGNCT07706790Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) in Healthy AdultsCOMPLETEDNCT07770555Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use DisorderNOT_YET_RECRUITING

Other records listing Brainsway , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251391BrainsWay Deep TMS SystemK251449BrainsWay Deep TMS SystemK222196Deep TMS SystemK220819BrainsWay Deep TMS SystemK210201Deep Transcranial Magnetic Stimulation (DTMS) SystemK203735Brainsway Deep TMS System

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Related Devices (Code: QMD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200957Brainsway Deep TMS SystemBrainsway , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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