# K180907: HORIZON TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Magstim Company, Ltd.
- Decided: Aug 3, 2018 after 119 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070003 (2008). 12 ancestors in all.
12 later devices descend from it; 2 cite 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)
- K171051: HORIZON Therapy System, Magstim Company, Ltd. (2017) Summary page 4.
- K160703: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016) Summary page 4.
- K173441: Neurosoft TMS (also CloudTMS), Teleemg, LLC (2017) Summary page 4.

## Most influential descendants
- K182853: HORIZON TMS Therapy System (2019), 10 descendants of its own
- K183376: HORIZON TMS Therapy System with Navigation (2019), 7 descendants of its own
- 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
- K232639: Apollo TMS Therapy System (2024), 3 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.
- Oct 25, 2018 · Class II · Z-0836-2019: A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.

## Indications for use
The HORIZON™ 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.

Source page: https://510kreport.com/device/K180907
Methodology: https://510kreport.com/methodology