Neuro / Head & NeckUS + EU
icobrain
🇧🇪icometrix · Brain MR quantification
What it does
Measures brain structures and lesion volumes on MR and reports them, so changes over time are tracked from numbers rather than eyeballed.
Who it's for
Neuroradiology teams following conditions such as MS or dementia where volume change matters.
Reported performance
No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.
Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.
FDA
Pathway510(k)
Submission #—
Product code—
Decision dateApr 1, 2020
PanelRadiology
EU (CE)
StatusCE-marked
Risk class—
Notified body—
EMDN code—
Basic UDI-DI—
AI Act class—
Vendor
Cite this page
RadPigeon. "icobrain (icometrix)." AI Devices registry. https://radpigeon.news/ai/device/icometrix-icobrain
Last updated Jun 29, 2026 · last verified Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.
