# K163013: Quantib Brain 1.2

- Pathway: 510(k) (Special)
- Applicant: Quantib B.V.
- Decided: Jan 6, 2017 after 70 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: 3 generations back to K011196 (2001). 3 ancestors in all.
4 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)
- K153351: Quantib Brain 1, Quantib B.V. (2016) Summary page 4.

## Most influential descendants
- K173939: Quantib Brain (2018), 3 descendants of its own
- K182564: Quantib ND (2018), 2 descendants of its own
- K213737: Quantib ND (2022), 1 descendant of its own
- K251527: Brain WMH (2025), 0 descendants of its own

## Indications for use
Quantib™ Brain 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™ Brain output consists of segmentations, visualizations and volumetric measurements of grey matter (GM), white matter (WM), and cerebrospinal fluid (CSF). The output also visualizes and quantifies white matter hyperintensity (WMH) candidates. Users need to review and if necessary, edit WMH candidates using the provided tools, before validation of the WMHs. 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™ Brain is a post-processing plugin for the GE Advantage Workstation (AW 4.7) or AW Server (AWS 3.2) platforms.

Source page: https://510kreport.com/device/K163013
Methodology: https://510kreport.com/methodology