FDA Product Code QKQ: Digital Pathology Image Viewing And Management Software
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.
Leading manufacturers include PathAI, Inc., Pathpresenter Corporation and Indica Labs, LLC.
FDA 510(k) Cleared Digital Pathology Image Viewing And Management Software Devices (Product Code QKQ)
About Product Code QKQ - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code QKQ since 2020, with 13 receiving FDA clearance (average review time: 219 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QKQ submissions have been consistent, averaging 209 days recently vs 242 days historically.
QKQ devices are reviewed by the Pathology panel. Browse all Pathology devices →