# K231837: Brainomix 360 Triage LVO

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Sep 28, 2023 after 98 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- 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: 2 generations back to DEN170073 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223042: Viz LVO ContaCT, Viz. Ai, Inc. (2022) Summary page 6.

## Indications for use
Brainomix Triage LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Brainomix Triage LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion (LVO) has been identified and recommends review of those images. Images can be previewed through a mobile application or via email. Brainomix Triage LVO is intended to analyze terminal ICA and MCA-M1 vessels for LVOs. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing noncompressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. Brainomix Triage LVO is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.

Source page: https://510kreport.com/device/K231837
Methodology: https://510kreport.com/methodology