Brainomix 360 Triage LVO
K231837Brainomix Limited · cleared 2023-09-28 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“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.”
Algorithmmachine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics
source quote (p.6)
“Brainomix 360 Triage LVO 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 on CTA imaging in the acute setting.”
Adaptive (vs locked)No
source quote (p.6)
“advanced non adaptive imaging algorithms”
PCCPNo
source quote (p.1)
“However, your 510(k) submission did not include a PCCP”
Cybersecurity addressedYes
source quote (p.13)
“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=308 scans · 14 site(s)
endpoints: sensitivity; specificity
standards: ISO 14971:2019
Reported performance (5 observations)
sensitivity0.9CI 84.2-94.3%
source quote (p.9)
“Sensitivity of 90% (95% CI: 84.2-94.3)”
specificity0.929CI 88.0-94.3%
source quote (p.9)
“Specificity 92.9% (95% CI: 88.0-94.3)”
aurocas written: “auc”0.914CI 88.2-94.5%
source quote (p.9)
“AUC of 91.4% (95% CI: 88.2-94.5)”
sensitivityas written: “Left hemisphere sensitivity”0.886CI 79.4-94.8%
source quote (p.9)
“left hemisphere (sensitivity = 88.6%, CI: 79.4-94.8%)”
sensitivityas written: “Right hemisphere sensitivity”0.914CI 83.0-96.7%
source quote (p.9)
“right hemisphere (91.4%, CI: 83.0-96.7%) LVOs.”
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).