Brainsway Deep TMS System
FDA 510(k) K200957 · Brainsway , Ltd.
510(k) numberK200957
Submission
- Device name
- Brainsway Deep TMS System
- Applicant
- Brainsway , Ltd.
Jerusalem, IL - Received
- April 9, 2020
- Decision date
- August 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QMD – Transcranial Magnetic Stimulation System For Smoking Cessation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5802
- Specialty
- Neurology
Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Other 510(k)s with product code QMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203616 | Brainsway Deep (DTMS) SystemQMD · Traditional | Brainsway , Ltd. | 04/16/2021SE |
More from Brainsway , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251391 | BrainsWay Deep TMS SystemOBP · Traditional | 11/07/2025SE |
| K251449 | BrainsWay Deep TMS SystemOBP · Traditional | 09/13/2025SE |
| K222196 | Deep TMS SystemOBP · Traditional | 05/31/2024SE |
| K220819 | BrainsWay Deep TMS SystemOBP · Traditional | 08/26/2022SE |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) SystemOBP · Traditional | 08/17/2021SE |
| K203735 | Brainsway Deep TMS SystemOBP · Traditional | 04/23/2021SE |
| K203616 | Brainsway Deep (DTMS) SystemQMD · Traditional | 04/16/2021SE |
| K183303 | Brainsway Deep TMS SystemQCI · Traditional | 03/08/2019SE |
| K173540 | Brainsway Deep (DTMS) SystemOBP · Traditional | 05/03/2018SE |
| K122288 | Brainsway Deep TMS SystemOBP · Traditional | 01/07/2013SE |
Questions and answers
When was Brainsway Deep TMS System cleared by the FDA?
Brainsway Deep TMS System (K200957) received a 510(k) decision of Substantially Equivalent on August 21, 2020, 134 days after the submission was received.
What is the product code of K200957?
The FDA product code is QMD – Transcranial Magnetic Stimulation System For Smoking Cessation, a Class II (moderate risk) device regulated under 21 CFR 882.5802.