# K183376: HORIZON TMS Therapy System with Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Magstim Company, Ltd.
- Decided: Apr 3, 2019 after 118 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to DEN070003 (2008). 17 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S (2018) Summary page 4.
- K180907: HORIZON TMS Therapy System, Magstim Company, Ltd. (2018) Summary page 4.

## Most influential descendants
- K211389: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation (2021), 6 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
- 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 (2023), 2 descendants of its own
- 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

## Recalls of this device
- Mar 23, 2020 · Class II · Z-1965-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
- Mar 23, 2020 · Class II · Z-1966-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

## Indications for use
HORIZON® 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.

Source page: https://510kreport.com/device/K183376
Methodology: https://510kreport.com/methodology