# K192130: Icobrain

- Pathway: 510(k) (Traditional)
- Applicant: Icometrix NV
- Decided: Dec 13, 2019 after 128 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: 4 generations back to K061855 (2006). 4 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K181939: icobrain, Icometrix NV (2018) Summary page 6.

## Most influential descendants
- K231929: iQ-solutions (2023), 0 descendants of its own
- K223659: Jazz (2023), 0 descendants of its own
- K223180: AIRAscore (2023), 0 descendants of its own

## Indications for use
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point. icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints. The results of icobrain cross cannot be compared with the results of icobrain long.

Source page: https://510kreport.com/device/K192130
Methodology: https://510kreport.com/methodology