DeviceClearance

Product code QKQ— Pathology

FullFocus

Classification name
Digital Pathology Image Viewing And Management Software
Device class
Class 2
Regulation
21 CFR 864.3700
Advisory panel
Pathology
Total cleared
14
First cleared
Most recent

FDA classification definition

“Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.”

— U.S. Food and Drug Administration, device classification record for product code QKQ under 21 CFR 864.3700, via openFDA

Market context for product code QKQ

FDA has cleared 14 devices under product code QKQ between 2020 and 2026, filed by 12 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 QKQ

Recent clearances under product code QKQ

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