# K182564: Quantib ND

- Pathway: 510(k) (Traditional)
- Applicant: Quantib B.V.
- Decided: Dec 27, 2018 after 100 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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 K011196 (2001). 5 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K173939: Quantib Brain, Quantib B.V. (2018) Summary page 4.

## Most influential descendants
- K213737: Quantib ND (2022), 1 descendant of its own
- K251527: Brain WMH (2025), 0 descendants of its own

## Indications for use
Quantib™ ND is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyperintensities. Volumetric measurements may be compared to reference centile data. 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. Quantib™ ND is a software application on top of Myrian®.

Source page: https://510kreport.com/device/K182564
Methodology: https://510kreport.com/methodology