FDA Product Code QPN: Software Algorithm Device To Assist Users In Digital Pathology
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.
Leading manufacturers include Paige.Ai and Ibex Medical Analytics , Ltd..
FDA 510(k) Cleared Software Algorithm Device To Assist Users In Digital Pathology Devices (Product Code QPN)
About Product Code QPN - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QPN since 2021, with 1 receiving FDA clearance (average review time: 266 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QPN submissions have been consistent, averaging 267 days recently vs 264 days historically.
QPN devices are reviewed by the Pathology panel. Browse all Pathology devices →