Brainomix 360 Triage Stroke
K232496Brainomix Limited · cleared 2023-11-21 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.”
source quote (p.6)
“Brainomix 360 Triage Stroke is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics to automatically identify suspected LVO and ICH on non-contrast CT (NCCT) imaging 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.”
source quote (p.6)
“machine learning algorithms that uses advanced non adaptive imaging algorithms”
Validation studies (2)
Retrospective clinical
n=267 cases
endpoints: assessing the performance of Brainomix 360 Triage Stroke in identifying NCCT head images containing intracranial hemorrhage (ICH) or large vessel occlusion (LVO) findings
standards: 21 CFR Part 820.30, EN ISO 14971:2019, IEC 62304:2015
Reader study (MRMC)
n=227 cases
endpoints: compare NCCT LVO sensitivity of the device to that of radiologists; expert non-inferiority; non-expert superiority
standards: 21 CFR Part 820.30, EN ISO 14971:2019, IEC 62304:2015
Reported performance (10 observations)
source quote (p.10)
“Specifically, ICH performance was observed at 92.5% sensitivity (95% CI: 80.97-98.36%)”
source quote (p.10)
“and 87.22% specificity (CI: 82.39-91.18%).”
source quote (p.10)
“NCCT LVO performance was observed at 68.75% sensitivity (CI: 59.71-76.90%)”
source quote (p.10)
“and 89.57% specificity (CI: 82.92-94.36%).”
source quote (p.10)
“Triage Stroke passed both conditions, with a sensitivity for all readers (experts and non-experts) of 47.94% (CI: 37.91-57.97%).”
source quote (p.10)
“The difference between the device's sensitivity and that of all readers was 20.52% (CI: 8.26-32.78%).”
source quote (p.10)
“The general radiologists (non-experts) performed with a sensitivity of 47.18% (CI: 33.62-60.75%).”
source quote (p.10)
“The difference between the device and non-expert sensitivity was 21.28% (CI: 5.84-36.72%).”
source quote (p.10)
“The results were a minimum expected time-to-notification of 62 seconds”
source quote (p.10)
“and a maximum of 134 seconds.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251983 (decision 2025-08-26) from Brainomix Limited for a matching device line ("Brainomix 360 Triage Stroke") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251983
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).