# K213706: AI-Rad Companion Brain MR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Apr 15, 2022 after 142 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: 17 generations back to K971684 (1997). 193 ancestors in all.
3 later devices descend from it; 2 cite it directly.
5 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193290: AI-Rad Companion Brain MR, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K232305: AI-Rad Companion Brain MR (2023), 1 descendant of its own
- K253057: AI-Rad Companion Brain MR (2026), 0 descendants of its own
- K240680: CDM Insights (2024), 0 descendants of its own

## 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 brain structure with normative data from a healthy population - Presentation of results of reporting that includes all numerical values as well as visualization of these results

Source page: https://510kreport.com/device/K213706
Methodology: https://510kreport.com/methodology