# K260406: Brainomix 360 Hyperdensity

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Jun 12, 2026 after 123 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: 6 generations back to K061855 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232363: Viz HDS, Viz Volume Plus, Viz ICH+, Viz. Ai, Inc. (2024) Summary page 5.

## Indications for use
Brainomix 360 Hyperdensity is intended for automatic labeling, visualization, and volumetric quantification of intracranial hyperdensities from a set of Non-Contrast CT (NCCT) head scans acquired at a single time point. The device output should be reviewed along with patient’s original images by a physician.

Source page: https://510kreport.com/device/K260406
Methodology: https://510kreport.com/methodology