510(k) Report

FDA applicant

Methinks Software, S.L

Barcelona, ES2 decisions2025–20250 recalls

FDA records 2 decisions for Methinks Software, S.L (Barcelona, ES) in 2025: 2 510(k) clearances. All are in product code QAS (Radiological Computer-Assisted Triage And…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Methinks Software, S.L’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Methinks Software, S.L by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Methinks Software, S.L’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report