# K231195: Brainomix 360 Triage ICH

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Jul 27, 2023 after 91 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193658: Viz ICH, Viz. Ai, Inc. (2020) Summary page 5.

## Indications for use
Brainomix 360 Triage ICH 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 360 Triage ICH 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 is intended to be used for the triage of non-contrast CT images of the brain acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage. The device sends notifications to a neurovascular specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application. 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 non-compressed 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 360 Triage ICH 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. Limitations: • Brainomix 360 Triage ICH is not intended for mobile diagnostic use. Images viewed on a mobile platform are preview images and not for diagnostic interpretation. • Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners. • Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage. • Brainomix 360 Triage ICH is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of intracranial hemorrhage. Contraindications: Brainomix 360 Triage ICH is not suitable for use with scan data containing image features associated with: • tumors or abscesses • coils, shunts, embolization or movement artefacts Brainomix 360 Triage ICH is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.

Source page: https://510kreport.com/device/K231195
Methodology: https://510kreport.com/methodology