# K223754: BraveCX

- Pathway: 510(k) (Traditional)
- Applicant: Bering, Ltd.
- Decided: Nov 9, 2023 after 329 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- 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 DEN170073 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211733: Lunit INSIGHT CXR Triage, Lunit, Inc. (2021) Summary page 5.

## Indications for use
BraveCX is a radiological computer-assisted triage and notification software that analyzes adult (≥18 years old) chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). BraveCX uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, BraveCX does not send a proactive alert directly to the appropriately trained medical specialists. BraveCX is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Source page: https://510kreport.com/device/K223754
Methodology: https://510kreport.com/methodology