DIGITAL LABORATORY MICROSCOPES

Primary DI

00815477020389

Basic UDI-DI Code

0815477020389WY

Reference

23SAMSWDXIVD

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Leica Biosystems Imaging, Inc.

The SAM DX Software is an accessory to Aperio GT 450 DX, it is not an IVD medical device in its own right. The SAM software is deployed on a server which is designed for centralized management of multiple scanner de-vices. This software facilitates lab management for large clinical operations with the following primary functions: • Present device activity • Present device information • Manage device configuration • Store and present device performance data • Store and archive device logs • Marshall slide acquisition data to image management system

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