Brainomix 360 Triage ICH
K231195Brainomix Limited · cleared 2023-07-27 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“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.”
Algorithmmachine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics
source quote (p.6)
“Brainomix 360 Triage ICH 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 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.”
Adaptive (vs locked)No
source quote (p.6)
“advanced non adaptive imaging algorithms”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Both proposed and predicate devices run on standard physical and/or virtual servers which are installed within a hospital network and within the protection of hospital firewalls.”
Validation studies (1)
Retrospective clinical
n=341 scans · 30 site(s)
endpoints: sensitivity; specificity; time to notification
Reported performance (3 observations)
sensitivity89.22
source quote (p.10)
“sensitivity (or positive percentage agreement, defined as TP/[TP+FN]) was 89.22%”
specificity91.37
source quote (p.10)
“specificity (or negative percentage agreement, defined as TN/[TN+FP]) was 91.37%.”
time_to_resultas written: “time to notification”stated without valueCI 50 seconds to 126 seconds
source quote (p.11)
“To assess the secondary outcome measure, the device's time to notification was recorded for a sample of cases. This ranged from 50 seconds to 126 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
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
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).