# K251983: Brainomix 360 Triage Stroke

- Pathway: 510(k) (Traditional)
- Applicant: Brainomix Limited
- Decided: Aug 26, 2025 after 60 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: 5 generations back to DEN170073 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232496: Brainomix 360 Triage Stroke, Brainomix Limited (2023) Summary page 7.

## Indications for use
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images 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 symmetrical bilateral MCA occlusions. Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Cautions: * All patients should get adequate care for their symptoms, including angiography and/or other appropriate care per the standard clinical practice, irrespective of the output of Brainomix 360 Triage Stroke. * Brainomix 360 Triage Stroke is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo angiography, per the standard stroke workup. Limitations: 1. Brainomix 360 Triage Stroke is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation. 2. Brainomix 360 Triage Stroke does not replace the need for angiography in ischemic stroke workup - it provides workflow prioritization and notification only. 3. Brainomix 360 Triage Stroke has been validated and is intended to be used on Siemens, GE and Philips scanners. 4. Brainomix 360 Triage Stroke 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 stroke. 5. Brainomix 360 Triage Stroke is not intended to detect symmetrical bilateral MCA occlusions. Contraindications: Brainomix 360 Triage Stroke is not suitable for use with scan data containing image features associated with: * tumours or abscesses

Source page: https://510kreport.com/device/K251983
Methodology: https://510kreport.com/methodology