# K261228: QuickVision Ultimate rTMS

- Pathway: 510(k) (Traditional)
- Applicant: Brain Ultimate, Inc.
- Decided: Aug 14, 2026 after 121 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: 9 generations back to DEN070003 (2008). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243460: Ultimate rTMS, Brain Ultimate, Inc. (2025) Summary page 5.
- K210109: visor2 system, Eemagine Medical Imaging Solutions GmbH (2022) Summary page 5.

## Indications for use
The QuickVision 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. The QuickVision Ultimate rTMS includes a neuronavigation system indicated to provide navigation and location support for placement of the TMS coil on the skull in relation to a prior acquired MRI image.

Source page: https://510kreport.com/device/K261228
Methodology: https://510kreport.com/methodology