DX-MIDI3-B0500CCAA

Nom de l'organisation

3DHISTECH Kft.

SRN

HU-MF-000014337

Statut du fabricant

Actif

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

05999571470273

Basic UDI-DI

599957147MID3UX

Numéro de référence/catalogue

DX-MIDI3-B0500CCAA

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe A

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The scanner is a diagnostic purpose in vitro medical device, a digital slide microscope that automatically creates a digital image of the inserted glass slides (such as surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue, cytology smear/specimen, peripheral blood smear, HE (hematoxylin-eosin-stained) tissue, IHC labeled tissue, or frozen section) used by a qualified health professional (pathologist). The scanner digitalises biological samples which are prepared to standard 25 mm wide slide. The dimension standard of the slide is ISO 8037-1. The digital microscope can be part of the diagnostic Pathology Management System, used by a trained healthcare professional (qualified pathologist), for qualitative, visual evaluation or quantitative analysis of digitised pathological specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the system.

URL des informations complémentaires

https://www.3dhistech.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0202050304DIGITAL LABORATORY MICROSCOPES

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