# K122288: Brainsway Deep TMS System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Jan 7, 2013 after 161 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: 2 generations back to DEN070003 (2008). 2 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN070003: Neurostar TMS System, Neuronetics (2008). Our reading of the summary gave K061053, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070003, Neurostar TMS System (Neuronetics), granted Oct 7, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K083538: Neurostar TMS Therapy System, Model 1.1, Neuronetics (2008) Summary page 1.

## Most influential descendants
- K173540: Brainsway Deep (DTMS) System (2018), 24 descendants of its own
- K210201: Deep Transcranial Magnetic Stimulation (DTMS) System (2021), 22 descendants of its own
- K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (2022), 16 descendants of its own
- K230029: NeuroStar Advanced Therapy System (Version 3.7) (2023), 13 descendants of its own
- K231926: NeuroStar Advanced Therapy System (All previously cleared models) (2024), 7 descendants of its own

## 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/K122288
Methodology: https://510kreport.com/methodology