# K193290: AI-Rad Companion Brain MR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 17, 2020 after 203 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: 16 generations back to K971684 (1997). 192 ancestors in all.
11 later devices descend from it; 3 cite it directly.
5 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182904: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2019) Summary page 5.

## Most influential descendants
- K220497: CoLumbo (2022), 6 descendants of its own
- K213706: AI-Rad Companion Brain MR (2022), 3 descendants of its own
- K241211: CoLumbo (2024), 2 descendants of its own
- K232305: AI-Rad Companion Brain MR (2023), 1 descendant of its own
- K254015: CoLumbo C-Spine (2026), 0 descendants of its own

## Indications for use
Al-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing and evaluating MR brain images. Al-Rad Companion Brain MR provides the following functionalities: - Automatic segmentation and quantitative analysis of individual brain structures - 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/K193290
Methodology: https://510kreport.com/methodology