# DEN170078: Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

- Pathway: De Novo (Direct)
- Applicant: Brainways, Ltd.
- Decided: Aug 17, 2018 after 322 days
- Product code: QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder)
- 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
No predicates in its family tree.
28 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K183303: Brainsway Deep TMS System (2019), 25 descendants of its own
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (2020), 24 descendants of its own
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (2022), 19 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 Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

Source page: https://510kreport.com/device/DEN170078
Methodology: https://510kreport.com/methodology