# K050703: Qbrain

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Apr 21, 2005 after 34 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: 1 generation back to K011196 (2001). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011196: Iquantify, Version 1.0, Insightful Corporation (2001) Summary page 1.

## Most influential descendants
- K153351: Quantib Brain 1 (2016), 5 descendants of its own
- K163013: Quantib Brain 1.2 (2017), 4 descendants of its own
- 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

## Indications for use
The QBrain software has been developed for the objective and reproducible analysis of MR images of the brain. It performs quantitative analysis of MR brain images based on automatic segmentation. More specifically, it quantifies the volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white matter hyperintensities (lesions). These parameters should only be used by trained medical professionals. They may be used to support diagnosis in clinical practice and to reach conclusions in clinical trials.

Source page: https://510kreport.com/device/K050703
Methodology: https://510kreport.com/methodology