# K232231: QP-Brain®

- Pathway: 510(k) (Traditional)
- Applicant: Quibim S.L.
- Decided: Dec 13, 2023 after 139 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K061855 (2006). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170981: NeuroQuant, Cortechs Labs, Inc. (2017) Summary page 5.

## Most influential descendants
- K250416: GBrain MRI (2025), 1 descendant of its own
- K252362: GBrain MRI (2025), 0 descendants of its own

## Indications for use
QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application is used by clinicians with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be based solely on the results of the device.

Source page: https://510kreport.com/device/K232231
Methodology: https://510kreport.com/methodology