DeviceClearance

Product code QPN— Pathology

Galen Second Read

Classification name
Software Algorithm Device To Assist Users In Digital Pathology
Device class
Class 2
Regulation
21 CFR 864.3750
Advisory panel
Pathology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QPN under 21 CFR 864.3750, via openFDA

Market context for product code QPN

FDA has cleared 2 devices under product code QPN between 2021 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QPN

Recent clearances under product code QPN

Data sourced from openFDA. This site is unofficial and independent of the FDA.