# K203735: Brainsway Deep TMS System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Apr 23, 2021 after 123 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to DEN070003 (2008). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S (2018) Summary page 4.
- K122288: Brainsway Deep TMS System, Brainsway, Ltd. (2013) Summary page 4.
- K173540: Brainsway Deep (DTMS) System, Brainsway, Ltd. (2018) Summary page 4.

## Indications for use
The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

Source page: https://510kreport.com/device/K203735
Methodology: https://510kreport.com/methodology