# K171481: MagVita TMS Therapy System

- Pathway: 510(k) (Special)
- Applicant: Tonica Elektronik A/S
- Decided: Jun 16, 2017 after 28 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). 6 ancestors in all.
48 later devices descend from it; 7 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160703: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016) Summary page 4.
- K150641: MagVita TMS Therapy System, Tonica Elektronik A/S (2015) Summary page 4.

## Most influential descendants
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation (2018), 39 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
- K173441: Neurosoft TMS (also CloudTMS) (2017), 17 descendants of its own
- K230029: NeuroStar Advanced Therapy System (Version 3.7) (2023), 13 descendants of its own

## Indications for use
The MagVita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to recieve satisfactory improvement from prior antidepressant medication in the current episode

Source page: https://510kreport.com/device/K171481
Methodology: https://510kreport.com/methodology
