Brainomix 360 e-ASPECTS
K221564Brainomix Limited · cleared 2023-02-23 · product code POK · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.3)
“The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) Score. 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.”
source quote (p.8)
“Physicians can, at their discretion and depending on their level of agreement with the processing results, manually edit the ASPECTS score by manually selecting ASPECTS regions to be included or excluded from the calculation of the ASPECTS score.”
Validation studies (4)
Bench
sample size not stated
standards: DICOM (Digital Imaging and Communications in Medicine), NEMA PS 3.1 - 3.20
Bench
n=200 other
Retrospective clinical
n=256 patients · 8 site(s)
Reader study (MRMC)
n=54 scans
endpoints: statistically significant improvement of AUC; increase in sensitivity; improvement in specificity; improvement in overall percentage agreement (accuracy)
standards: ISO 14971:2007/(R)2016
Reported performance (6 observations)
source quote (p.16)
“Overall performance in 256 patients showed an area under the curve of 83% (81-85, 95% CI), with a sensitivity of 68% (57-72) and a specificity of 97% (86-98).”
source quote (p.16)
“Overall performance in 256 patients showed an area under the curve of 83% (81-85, 95% CI), with a sensitivity of 68% (57-72) and a specificity of 97% (86-98).”
source quote (p.16)
“Overall performance in 256 patients showed an area under the curve of 83% (81-85, 95% CI), with a sensitivity of 68% (57-72) and a specificity of 97% (86-98).”
source quote (p.17)
“Overall percentage agreement (accuracy) also improved in line with the AUC result from 93 to 94%.”
source quote (p.17)
“the improved AUC in the primary endpoint was driven by an increase in both the sensitivity (positive percentage agreement, from 66 to 70%)”
source quote (p.17)
“and a small improvement in specificity (negative percentage agreement, 96%) when assisted by e-ASPECTS compared to unassisted reading.”
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) 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). 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).