Aiforia® Clinical AI Model for Breast Cancer; ER

Nom de l'organisation

Aiforia Technologies Plc

SRN

FI-MF-000008986

Statut du fabricant

Actif

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

Dénomination commerciale

Aiforia® Clinical AI Model for Breast Cancer; ER

Code d'UDI-DI

06429810612038

Basic UDI-DI

B-06429810612038

Numéro de référence/catalogue

Aiforia® Clinical AI Model for Breast Cancer; ER

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Aiforia® Clinical AI Model for Breast Cancer; ER is intended for use with digital images of ER-stained invasive breast cancer of human specimens. The product supports the detection of tumor epithelium and scoring of ER-positive and ER-negative cells of epithelial origin from whole slide images (WSI) or from selected image areas. The product enables viewing and selection of areas with high density of ER-positive cells (hotspots) and displays results of image analysis. A medical professional can view images for a patient case in different magnifications, view image analysis results, and mark and measure features in the images. The Aiforia® Clinical AI Model for Breast Cancer; ER supports user’s visual interpretation and assists the medical professional in making the diagnosis and should not be used as the sole basis for diagnosis. The product is intended to be used by qualified medical professionals.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0202050392LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE

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