CINA-ASPECTS

Nom de l'organisation

Avicenna.AI

SRN

FR-MF-000000324

Statut du fabricant

Actif

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• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en France ; disponible dans 32 pays au total.

Dénomination commerciale

CINA-ASPECTS

Code d'UDI-DI

+B826CINAASPECTS140

Basic UDI-DI

++B826CINAASPECTS14NS

Numéro de référence/catalogue

CINA-ASPECTS

Entité d'attribution

HIBCC

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

https://my.avicenna.ai/portal/en/signin

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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