# K223180: AIRAscore

- Pathway: 510(k) (Traditional)
- Applicant: Airamed GmbH
- Decided: Aug 25, 2023 after 318 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 K061855 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192130: Icobrain, Icometrix NV (2019) Summary page 4.

## Indications for use
AlIRAscore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR 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 images.

Source page: https://510kreport.com/device/K223180
Methodology: https://510kreport.com/methodology