DIGITAL LABORATORY MICROSCOPES

Primary DI

00815477020297

Basic UDI-DI Code

0815477020297WS

Reference

23GT450DXIVD

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Leica Biosystems Imaging, Inc.

The Aperio GT 450 DX scanner is an automated digital slide creation instrument. The Aperio GT450 DX scanner is intended for in vitro diagnostic use as an aid to the pathologist to create digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT450 DX scanner is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The Aperio GT450 DX scanner is for creation of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. 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 Aperio GT 450 DX System. Aperio GT450 DX scanner is intended for use with compatible Digital Pathology Image Viewing Software.

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