CINA-ASPECTS

Primary DI

B826CINAASPECTS140

Basic UDI-DI Code

B-B826CINAASPECTS140

Reference

++B826CINAASPECTS14NS

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Avicenna.AI

CINA ASPECTS is a computer-aided diagnostic (CADx) software device indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist trained clinicians, including stroke physicians and radiologists, in the assessment and characterization of early ischemic brain tissue injury using CT image data. The Software automatically reorients images, segments and analyzes ASPECTS Regions of Interest (ROIs). The imaging features are then synthesized by an artificial intelligence algorithm into a single informative ASPECT (Alberta Stroke Program Early CT) Score. CINA ASPECTS is indicated for evaluation of patients presenting with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. CINA ASPECTS is not intended for primary interpretation of CT images, it is used to assist clinician evaluation in conjunction with other patient information. The automatically generated ASPECT score is provided for informational purposes only, and is not intended to displace the ASPECT score on patient medical records as established by clinicians which are ultimately responsible for reviewing full images per the ASPECTS standard of care radiologist assessment.

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