CS-META

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-META

Code d'UDI-DI

08437027144028

Basic UDI-DI

B-08437027144028

Numéro de référence/catalogue

CS-META 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-META algorithm is intended for screening the pathological state in oesophageal samples: It detects the presence of intestinal metaplasia in the oesophagus (Barrett's oesophagus), with or without dysplasia. Helps in the diagnosis of pathological state due to the presence of metaplasia. It provides specific information about a physiological or pathological state. Qualitative automated algorithm that integrates AI. It uses oesophageal tissue samples from patients of any gender and age. Therefore, the purpose of the algorithm is to provide the pathologist or health professional who uses it with an automatic identification of the findings, facilitating the reading of the areas with the presence of metaplasia, on an image of a processed oesophageal biopsy sample. This is done by showing the possible areas of interest, so that the pathologist can make a faster and safer diagnosis, less influenced by individual variability between observers as it is standardized. The diagnosis provided by the algorithm is not definitive: it must always be validated by the pathologist, who must check the veracity and accuracy of the information generated by the algorithm.

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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