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..
List of Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm devices (product code QYV). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Pathology FDA review panel. Browse all Pathology devices →