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FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

Authorized purpose: Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2 and sends PACS and/or specialist notifications in parallel to standard care; previews are informational and not diagnostic.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-08-20
FDA-cleared K250685

Methinks NCCT Stroke

Methinks Software S.L.

Authorized purpose: Methinks NCCT Stroke analyzes adult non-contrast head CT to flag suspected intracranial hemorrhage and suspected large-vessel occlusion of the ICA, MCA-M1, or MCA-M2 for parallel workflow triage via PACS and/or notifications; previews are informational, not diagnostic, and a negative notification does not rule out LVO or replace CTA/standard care.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-06-16