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The Tracker / October 2026 / K262147

510(k) cleared

CINA-Aneurysm+

Avicenna.Ai · Oct 19, 2026 · K262147

FDA cleared the CINA-Aneurysm+ from Avicenna.Ai on Oct 19, 2026 under K262147, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 25, 2026. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Avicenna.Ai has one other decision in the tracker over the last 12 months: K262062 (CINA-Aneurysm).

Questions & Answers

What did FDA clear under K262147?

K262147 is the FDA 510(k) for CINA-Aneurysm+, submitted by Avicenna.Ai. FDA's decision date was Oct 19, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the CINA-Aneurysm+?

Avicenna.Ai, based in La Ciotat, is the applicant of record for K262147.

How long did the K262147 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Oct 19, 2026, 116 days later.

← All decisions in October 2026

Sources