# K220819: BrainsWay Deep TMS System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Aug 26, 2022 after 158 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: 5 generations back to DEN070003 (2008). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210201: Deep Transcranial Magnetic Stimulation (DTMS) System, Brainsway, Ltd. (2021) Summary page 4.

## Most influential descendants
- K243319: Ampa One System (AMPA-001) (2025), 1 descendant of its own
- K251210: Ampa One System (AMPA-001) (2025), 0 descendants of its own

## Indications for use
The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

Source page: https://510kreport.com/device/K220819
Methodology: https://510kreport.com/methodology