# K203616: Brainsway Deep (DTMS) System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Apr 16, 2021 after 127 days
- Product code: QMD (Transcranial Magnetic Stimulation System For Smoking Cessation)
- Device class: 2
- Regulation: 21 CFR 882.5802
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170078 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200957: Brainsway Deep TMS System, Brainsway, Ltd. (2020) Summary page 5.

## Indications for use
The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.

Source page: https://510kreport.com/device/K203616
Methodology: https://510kreport.com/methodology