Brainomix 360 e-ASPECTS

K221564

Brainomix Limited · cleared 2023-02-23 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.”
Algorithmmachine learning algorithms; random forest machine learning technique
source quote (p.6)
“Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT (Non-contrast CT scans) brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines. The score includes which ASPECT regions are identified based on a voxel-wise analysis of non-contrast computed tomography (NCCT) brain image data based on the random forest machine learning technique.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Standalone

n=256 scans · 8 site(s)

Bench

n=200 other

endpoints: correlation between the volumes of the e-ASPECTS heatmaps and the volumes of synthetic hypodensities

Reader study (MRMC)

n=54 scans

endpoints: statistically significant improvement of AUC for each reader with and without the support of the e-ASPECTS tool

Reported performance (3 observations)

sensitivity0.68CI 57-72
source quote (p.16)
“with a sensitivity of 68% (57-72)”
specificity0.97CI 86-98
source quote (p.16)
“and a specificity of 97% (86-98).”
aurocas written: “auc”0.83CI 81-85, 95% CI
source quote (p.16)
“Overall performance in 256 patients showed an area under the curve of 83% (81-85, 95% CI)”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243294 (decision 2025-02-14) from Brainomix Limited for a matching device line ("Brainomix 360 e-ASPECTS") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243294

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/K221564