# K213737: Quantib ND

- Pathway: 510(k) (Special)
- Applicant: Quantib B.V.
- Decided: Jan 14, 2022 after 46 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: 6 generations back to K011196 (2001). 6 ancestors in all.
1 later device descends 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)
- K182564: Quantib ND, Quantib B.V. (2018) Summary page 4.

## Most influential descendants
- 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.

Source page: https://510kreport.com/device/K213737
Methodology: https://510kreport.com/methodology