# K253098: Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

- Pathway: 510(k) (Traditional)
- Applicant: Nexstim Oyj
- Decided: Mar 20, 2026 after 178 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: 13 generations back to DEN070003 (2008). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241518: Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0), The Magstim Company Limited (2024) Summary page 5.

## Indications for use
The Nexstim Navigated Brain Stimulation (NBS) 6 System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD).

Source page: https://510kreport.com/device/K253098
Methodology: https://510kreport.com/methodology