CINA

Primary DI

B826CINA100

Basic UDI-DI Code

B-B826CINA100

Reference

++B826CINA10RR

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Avicenna.AI

CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiographies of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) CT angiographies of the head for large vessel occlusion (LVO). CINA uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).