# K232235: Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Oct 25, 2023 after 90 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: 11 generations back to DEN070003 (2008). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222171: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+, Magstim Company, Ltd. (2023) Summary page 5.

## Most influential descendants
- 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) (2024), 1 descendant of its own
- K253098: Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (2026), 0 descendants of its own

## Indications for use
Horizon 3.0 TMS Therapy 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/K232235
Methodology: https://510kreport.com/methodology