Methinks CTA Stroke— 510(k) K251590

Substantially Equivalent

Methinks Software, S.L

FDA 510(k) clearance K251590 for Methinks CTA Stroke, Substantially Equivalent on 2025-08-20. Applicant: Methinks Software, S.L. Device class: 2.

Clearance details

Applicant: Methinks Software, S.L
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2025-05-23
Decision date: 2025-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAS

K261085 — Rapid Vessel Occlusion (Rapid VO)2026-07-13
K260729 — Vascular Assist Occlusion Triage (VAOT) (v1.0)2026-06-18
K261317 — BriefCase-Triage2026-05-14
K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)2026-04-22
K252421 — JLK-NCCT2026-03-24

More clearances from Methinks Software, S.L

K250685 — Methinks NCCT Stroke2025-06-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.