K250685

Methinks NCCT Stroke

510(k) number
K250685
Device name
Methinks NCCT Stroke
Applicant
Methinks Software, S.L ES
Product code
QAS — Radiological Computer-Assisted Triage And Notificati
Decision date
2025-06-16
Date received
2025-03-06
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K250685.pdf

Official FDA record: K250685
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.