Cleared Traditional

CINA-ASPECTS

K233342 · Avicenna.Ai · Radiology

Mar 2024

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K233342 is an FDA 510(k) clearance for the CINA-ASPECTS, a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code POK), submitted by Avicenna.Ai (La Ciotat, FR). The FDA issued a Cleared decision on March 15, 2024, 168 days after receiving the submission on September 29, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2060.

Submission Details

510(k) Number	K233342 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2023
Decision Date	March 15, 2024
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	POK — Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2060
Definition	Assist Users In Characterizing Lesions Identified On Acquired Medical Images