De Novo · Granted
GrantedBrainsway Deep Transcranial Magnetic Stimulation (DTMS) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainways, Ltd. · QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Granted on Aug 17, 2018 as a new device type through De Novo after a 322-day review. 28 later devices descend from it.
- Decided
- Aug 17, 2018
- Review
- 322 days
- Class
- Class II
- Product code
- QCI
- Recalls
- None
28 later devices descend from it, 3 citing it directly.
- This deviceDEN170078 Brainsway Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainways, Ltd. · 2018
- Descendant · cites it directly · 25 of its ownK183303 Brainsway Deep TMS SystemBrainsway, Ltd. · 2019
- Descendant · cites it directly · 24 of its ownK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- Descendant · 2 generations on · 19 of its ownK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- Descendant · 3 generations on · 13 of its ownK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- Descendant · 4 generations on · 7 of its ownK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K183303Brainsway Deep TMS SystemBrainsway, Ltd. · 2019 · cites it directly25descendants
- K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020 · cites it directly24descendants
- K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022 · 2 generations on19descendants
- K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023 · 3 generations on13descendants
- K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways, Ltd. | 2018 | — |
| +1 | K183303 | Brainsway Deep TMS System | Brainsway, Ltd. | 2019 | — |
| +1 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| +2 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| +3 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| +4 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QCI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QCI device
- #1 K212289 NeuroStar Advanced Therapy for adjunctive…score 17.7 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (28)
See all 283 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K183303 (Brainsway, Ltd., 2019) has gone furthest, with 25 descendants of its own.
How does its category compare?
All QCI devicesQCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QCI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QCI
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QCI
No recall names QCI since 2007.
Adverse event reports per year · QCI
2in 2024
MAUDE reports naming product code QCI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 3 | 30 | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170078 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170078: Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170078
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026