Brainomix 360 Triage LVO

K231837

Brainomix Limited · cleared 2023-09-28 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Brainomix 360 Triage LVO is a radiological computer aided triage and notification (CADt) software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. The Triage LVO module is a CTA processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification prioritization of suspected LVO. 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.”
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)
“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.”
PCCPNo
source quote (p.1)
“However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.”
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=308 cases · 14 site(s)

endpoints: detection of large vessel occlusion (LVO) in the brain

standards: ISO 14971:2019

Reported performance (4 observations)

sensitivity90CI 84.2-94.3
source quote (p.9)
“The observed results are Sensitivity of 90% (95% CI: 84.2-94.3) and Specificity 92.9% (95% CI: 88.0-94.3) with a receiver operating curve (ROC) AUC of 91.4% (95% CI: 88.2-94.5), as shown in Figure 1.”
specificity92.9CI 88.0-94.3
source quote (p.9)
“The observed results are Sensitivity of 90% (95% CI: 84.2-94.3) and Specificity 92.9% (95% CI: 88.0-94.3) with a receiver operating curve (ROC) AUC of 91.4% (95% CI: 88.2-94.5), as shown in Figure 1.”
aurocas written: “auc”91.4CI 88.2-94.5
source quote (p.9)
“The observed results are Sensitivity of 90% (95% CI: 84.2-94.3) and Specificity 92.9% (95% CI: 88.0-94.3) with a receiver operating curve (ROC) AUC of 91.4% (95% CI: 88.2-94.5), as shown in Figure 1.”
time_to_resultas written: “time-to-notification”stated without valueCI 86.3 to 178.2 seconds
source quote (p.12)
“The total time-to-notification ranged from 86.3 to 178.2 seconds, meeting the goal of time-to-notification of 3.5minutes, as the reference device Rapid LVO 1.0 (K200941).”

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K231837