# K243460: Ultimate rTMS

- Pathway: 510(k) (Traditional)
- Applicant: Brain Ultimate, Inc.
- Decided: Apr 17, 2025 after 160 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: 8 generations back to DEN070003 (2008). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 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 5.
- K171481: MagVita TMS Therapy System, Tonica Elektronik A/S (2017) Summary page 5.

## Most influential descendants
- K261228: QuickVision Ultimate rTMS (2026), 0 descendants of its own

## Indications for use
The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

Source page: https://510kreport.com/device/K243460
Methodology: https://510kreport.com/methodology