FDA applicant
Avicenna.Ai
FDA records 9 decisions for Avicenna.Ai (La Ciotat, FR) from 2020 to 2026: 9 510(k) clearances. Most are in product codes QAS (Radiological Computer-Assisted Triage And…) and QFM (Radiological Computer-Assisted Prioritization…). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 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
How often FDA has decided Avicenna.Ai’s devices, and how often a recall has named them.
FDA decisions per year
4in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Avicenna.Ai’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) ReportOther applicant names beginning “Avicenna.Ai”
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