Cleared Traditional

CINA CHEST

K210237 · Avicenna.Ai · Radiology

May 2021

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K210237 is an FDA 510(k) clearance for the CINA CHEST, a Radiological Computer-assisted Triage And Notification Software (Class II — Special Controls, product code QAS), submitted by Avicenna.Ai (La Ciotat, FR). The FDA issued a Cleared decision on May 19, 2021, 111 days after receiving the submission on January 28, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number	K210237 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2021
Decision Date	May 19, 2021
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QAS — Radiological Computer-assisted Triage And Notification Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2080
Definition	Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .