PANNORAMIC 480 DX Digital Scanner

Primary DI

05999571470365

Basic UDI-DI Code

599957147036S5

Reference

DX-04801-B1200AAAA

Device Types

New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

3DHISTECH Kft.

The scanner is a digital slide microscope that automatically creates a digital image of the inserted glass slides. The digital microscope can be part of the diagnostic Pathology Management System, it uses barcode-based slide recognition and communication to identify the slides (with the CaseManager DX report inventory system). The Pathology Management System is intended to be used to analyze and evaluate pathological specimens, and this product assists the pathologist in reviewing and interpreting digital images of a surgical pathology (histology) study that includes PANNORAMIC® 480 DX Digital Scanner. Digital slides can be displayed, reviewed and analyzed using the slide viewer and image analysis module of CaseManager DX. 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.

The Basic UDI-DI associated with this device has 7 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).