FDA Cleared
New Device
✦ AI/ML Enabled (Radiology)
Pathway: 510K
CINA-Aneurysm
Applicant:
Avicenna.Ai
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
QBS
Review Panel:
Radiology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-06-18
Decision Date:
2026-10-20
Total Review Duration:
124 calendar days (124 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Stéphane Berger
Role: SUBMITTER_CONTACT
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