CINA-ASPECTS

Primary DI

+B826CINAASPECTS140

Basic UDI-DI Code

++B826CINAASPECTS14NS

Reference

CINA-ASPECTS

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Avicenna.AI

CINA-ASPECTS is an Image Processing Application, which can be integrated, deployed and used with compatible medical image communications devices. CINA-ASPECTS receives non-contrast head CT (NCCT) scans identified by the medical image communications device, processes them using algorithmic methods involving execution of multiple computational steps to generate the ASPECT score and results files to be transferred by the medical image communications device for output to a PACS system or workstation. Series are processed by running the CINA-ASPECTS Image Processing Application on non-contrast head CT images (NCCT) to perform the: ● Orientation, tilt-correction of the input imaging data, ● Delineation of predefined regions of interest on the corrected input data and computing numerical values characterizing underlying voxel values within those regions, ● Highlighting areas of early ischemic changes, ● Labeling of these delineated regions and providing a summary score reflecting the number of regions with early ischemic change as per ASPECTS guidelines. The Worklist Client Application (provided by the medical image communications device) displays the generated ASPECT Score and results provided to the clinician for review and verification.The automatically generated ASPECT score is provided for informational purposes; the definite ASPECT being 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 2b) and regulation (EU MDR).