# K251527: Brain WMH

- Pathway: 510(k) (Traditional)
- Applicant: Quantib B.V.
- Decided: Sep 25, 2025 after 129 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: 7 generations back to K011196 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213737: Quantib ND, Quantib B.V. (2022) Summary page 5.

## Indications for use
Intended Use Brain WMH is intended for automatic labeling, visualization, and volumetric quantification of WMH from T2w FLAIR MR images. The output consists of segmentations, visualizations and volumetric measurements of WMH. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Intended User Population The intended users of Brain WMH are trained medical professionals. Intended Patient Population Brain WMH is intended for post-processing of brain magnetic resonance imaging (MRI) data from patients 22 years of age or older, without pathologies (e.g. tumor or stroke), and treatment induced features (e.g. from prior surgery or radiation treatment), and without contrast enhancement.

Source page: https://510kreport.com/device/K251527
Methodology: https://510kreport.com/methodology