# K232363: Viz HDS, Viz Volume Plus, Viz ICH+

- Pathway: 510(k) (Traditional)
- Applicant: Viz. Ai, Inc.
- Decided: Feb 5, 2024 after 182 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: 5 generations back to K061855 (2006). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211222: qER-Quant, Qure.Ai Technologies (2021) Summary page 5.

## Most influential descendants
- K260406: Brainomix 360 Hyperdensity (2026), 0 descendants of its own
- K250354: Viz Subdural+, Viz SUBDURAL PLUS (2025), 0 descendants of its own

## Indications for use
The Viz HDS device is intended for automatic labeling, visualization, and quantification of segmentable brain structures from a set of Non-Contrast CT (NCCT) head scans. The software is intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on NCCT images. Viz HDS provides volumes from NCCT scans acquired at a single time point. The Viz HDS software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift. The device output should be reviewed along with patient’s original images by a physician.

Source page: https://510kreport.com/device/K232363
Methodology: https://510kreport.com/methodology