VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Primary DI

00860006054526

Basic UDI-DI Code

0860006054526R7

Reference

Concentriq Dx

Device Types

New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Proscia, Inc.

Concentriq® Dx is a digital slide viewing and management software system. The system is intended to manage and display digital images of anatomic pathology glass slides for pathologist review, interpretation, and primary diagnosis. Concentriq Dx is not intended for use with digital images from frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images when using Concentriq Dx. Concentriq Dx does not directly detect or measure any specific disorder, condition, or risk factor; does not provide qualitative, semi-quantitative or quantitative result outputs; and is not intended for use with any specific testing population and is not a Companion Diagnostic.

The Basic UDI-DI associated with this device has 3 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).