# K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

- Pathway: 510(k) (Traditional)
- Applicant: Tonica Elektronik A/S
- Decided: Aug 9, 2020 after 286 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
Longest line of descent: 8 generations back to DEN070003 (2008). 15 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170078: Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System, Brainways, Ltd. (2018) Summary page 4.
- K183303: Brainsway Deep TMS System, Brainsway, Ltd. (2019) Summary page 4.
- K150641: MagVita TMS Therapy System, Tonica Elektronik A/S (2015) Summary page 5.
- K171481: MagVita TMS Therapy System, Tonica Elektronik A/S (2017) Summary page 5.
- K171967: MagVita TMS Therapy System, Tonica Elektronik A/S (2017) Summary page 5.
- K172667: MagVita TMS Therapy w/MagPro R20, Tonica Elektronik A/S (2017) Summary page 5.
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S (2018) Summary page 5.

## Most influential descendants
- 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
- K222171: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (2023), 4 descendants of its own
- K251119: MagVenture TMS Therapy System (2025), 3 descendants of its own

## Indications for use
The MagVenture TMS Therapy System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Source page: https://510kreport.com/device/K193006
Methodology: https://510kreport.com/methodology