# K160703: NeuroStar TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Neuronetics, Inc.
- Decided: Jun 10, 2016 after 88 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: 4 generations back to DEN070003 (2008). 4 ancestors in all.
55 later devices descend from it; 8 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133408: Neurostar TMS Therapy System, Neuronetics (2014) Summary page 4.

## Most influential descendants
- K171481: MagVita TMS Therapy System (2017), 48 descendants of its own
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation (2018), 39 descendants of its own
- K161519: NeuroStar TMS Therapy System (2016), 27 descendants of its own
- K201158: NeuroStar Advanced Therapy (2020), 24 descendants of its own
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (2020), 24 descendants of its own

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

Source page: https://510kreport.com/device/K160703
Methodology: https://510kreport.com/methodology