QPN

Software Algorithm Device To Assist Users In Digital Pathology

Product code

QPN

Device name

Software Algorithm Device To Assist Users In Digital Pathology

Device class

Class 2

21 CFR

21 CFR 864.3750

Medical specialty

Pathology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification definition

A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-01-24.