FDA.report

510(k) K251590

Device
Methinks CTA Stroke
Applicant
Methinks Software, S.L
510(k) number
K251590
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-20
Date received
2025-05-23
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Claudia Carbonell
Address
Pier 01, Plaça De Pau Vila, Office 2d2 Barcelona ES 08039 08039

FDA Registration Numbers

Source Documents

510(k) summary PDF

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