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Last updated: June 5, 2026
Back to directoryFDA-cleared computer-aided diagnosis software from Avicenna.AI that calculates ASPECTS from non-contrast head CT and supports clinician assessment of acute ischemic stroke severity.
Stroke programs that need standardized ASPECTS support, region-level visualization, and radiologist or stroke-physician review within an acute stroke pathway.
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Product-specific review. These product-specific signals summarize what the cited sources imply before treating Avicenna.AI CINA-ASPECTS as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match CINA-ASPECTS to FDA 510(k) K233342, local CE or other market status, exact intended use, software version, age range, scanner manufacturer, and acute-stroke context before using outputs in care decisions. |
|---|---|
| Privacy | Review DICOM routing, identifiers, cloud or on-premise processing, user access, audit logs, retention, support access, incident response, and customer data-processing terms; the public privacy policy mainly covers website interactions and points buyers to compliance documents. |
| Evidence | Evaluate performance on local non-contrast head CT studies against neuroradiologist or stroke-team ASPECTS assessment, including artifacts, scanner mix, early ischemic changes, excluded pathologies, and treatment-decision impact. |
| Workflow | Best governed as clinician-reviewed ASPECTS decision support inside an acute stroke protocol, with explicit ownership for reviewing heat maps, resolving AI-clinician disagreement, documenting decisions, and monitoring drift. |
Avicenna.AI describes CINA-ASPECTS as a neurovascular imaging tool that analyzes non-enhanced head CT to calculate ASPECTS, provide heat maps, and support stroke severity assessment; FDA materials list 510(k) K233342 for CINA-ASPECTS and state it is not intended for primary CT interpretation, with validation and use limits around known MCA or ICA occlusion, adult patients over 21, specific scanner manufacturers, and acute brain ischemia within 12 hours from last known well.
Not for: Primary CT interpretation, patients outside the cleared indication, unsupported scanner or pathology contexts, or bypassing neurologist and radiologist review for thrombectomy or thrombolysis decisions.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.