# K253057: AI-Rad Companion Brain MR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Jan 22, 2026 after 122 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 19 generations back to K971684 (1997). 195 ancestors in all.
No later device cites it as a predicate yet.
5 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232305: AI-Rad Companion Brain MR, Siemens Medical Solutions U.S.A. (2023) Summary page 6.

## Indications for use
AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images. AI-Rad Companion Brain MR provides the following functionalities. • Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities • Quantitative comparison of each brain structure with normative data from a healthy population • Presentation of results for reporting that includes all numerical values as well as visualization of these results

Source page: https://510kreport.com/device/K253057
Methodology: https://510kreport.com/methodology