CS-PHH3

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-PHH3

Code d'UDI-DI

08437027144035

Basic UDI-DI

B-08437027144035

Numéro de référence/catalogue

CS-PHH3 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-PHH3 algorithm is intended for screening pathological conditions in stomach tissue samples: - Detects the presence of mitotic cells in malignant tumors. - Assists in diagnosing pathological conditions related to the presence of mitotic cells in malignant tumors. - Provides specific information about a physiological or pathological state. - A quantitative automated algorithm that integrates Artificial Intelligence. - Uses tumor 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 interpretation of areas with mitotic cells on an image of a processed biopsy of tumor tissue. This is achieved by highlighting potential areas of interest so that the pathologist can make a faster and safer diagnosis, less influenced by inter-observer variability since it 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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