# K231398: VUNO Med-DeepBrain

- Pathway: 510(k) (Traditional)
- Applicant: Vuno, Inc.
- Decided: Oct 4, 2023 after 142 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: 3 generations back to K061855 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171328: cNeuro cMRI, Combinostics OY (2018) Summary page 6.

## Indications for use
The VUNO Med-DeepBrain is intended for automatic labeling, quantification and visualization of segmentable brain structures from a set of MR images. The software is intended to automate the current manual process of identifying, labeling and quantifying segmentable brain structures identified on MR images. The users are trained healthcare professionals who work with medical imaging. The product is used in an office-like environment.

Source page: https://510kreport.com/device/K231398
Methodology: https://510kreport.com/methodology