CINA-Aneurysm+— 510(k) K262147

Substantially Equivalent

Avicenna.Ai

FDA 510(k) clearance K262147 for CINA-Aneurysm+, Substantially Equivalent on 2026-10-19. Applicant: Avicenna.Ai. Device class: 2.

Clearance details

Applicant: Avicenna.Ai
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-06-25
Decision date: 2026-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Ciotat, FR

Download summary PDF View on FDA.gov ↗

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