FDA Product Code QYV: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
The Digital Cervical Cytology Slide Imaging System With Artificial Intelligence (ai) Algorithm Is A Prescription In Vitro Diagnostic Device Consisting Of An Automated Digital Slide Creation, Viewing, And Management System Intended To Aid In The Review Of Digital Images Of Slides Prepared From Pap Test Specimens And Conventional Pap Smears By Selecting And Presenting Areas Of Interest To Facilitate Interpretation By The Reader. The Ai Software Algorithm Uses Machine Learning Techniques To Provide Information To The User About The Presence, Location, Or Characteristics Of Areas Of The Image With Clinical Implications. Information From This Device Is Intended To Assist The User In Rendering A Cytology Diagnosis.
Leading manufacturers include Hologic, Inc..
FDA 510(k) Cleared Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm Devices (Product Code QYV)
About Product Code QYV - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QYV since 2024, with 0 receiving FDA clearance (average review time: 887 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QYV devices are reviewed by the Pathology panel. Browse all Pathology devices →