# K240680: CDM Insights

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Brain Diagnostics, Ltd.
- Decided: Dec 6, 2024 after 270 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: 18 generations back to K971684 (1997). 205 ancestors in all.
No later device cites it as a predicate yet.
5 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213706: AI-Rad Companion Brain MR, Siemens Healthcare GmbH (2022) Summary page 5.
- K210831: OnQ Neuro, Cortechs Labs, Inc. (2021) Summary page 7.

## Indications for use
CDM Insights is a post-processing image analysis software that assists trained healthcare practitioners in viewing, analyzing, and evaluating MR brain images of adults > 45 years of age. CDM Insights provides the following functionalities: • Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities • Quantitative comparison of brain structures and derived values with normative data from a healthy population • Presentation of results for reporting that includes numerical values as well as visualization of these results

Source page: https://510kreport.com/device/K240680
Methodology: https://510kreport.com/methodology