CS-BreastCancer HER2

Nom de l'organisation

CELLS IA TECHNOLOGIES S.L.

SRN

ES-MF-000042517

Statut du fabricant

Actif

Marché principal en Espagne ; disponible dans 1 pays au total.

Commercialisé en Espagne ; dates par pays non publiées.

Dénomination commerciale

CS-BreastCancer HER2

Code d'UDI-DI

08437027144127

Basic UDI-DI

B-08437027144127

Numéro de référence/catalogue

CS-BreastCancer HER2 V0.0.0

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 CS-BreastCancer HER2 algorithm is intended for cancer screening in breast tissue samples: - Detects cells positive for the HER2 antibody. - Assists in the diagnosis of pathological conditions by identifying the presence of the HER2 antibody. - Provides specific information on a physiological or pathological state. - Automated quantitative algorithm that integrates Artificial Intelligence. - Uses breast tissue samples from patients of any gender and age. Therefore, the purpose of the algorithm is to provide the pathologist or healthcare professional using it with an automatic identification of findings, facilitating the reading of areas with the presence of cells positive for the HER2 antibody on an image of a processed breast tissue sample. This is done by highlighting possible areas of interest so that the pathologist can make a faster and safer diagnosis, less influenced by individual variability between observers, since the process is standardized. The diagnosis provided by the algorithm is not definitive: it must always be validated by the pathologist, who confirms the accuracy of the generated information.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W02069092VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

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