Pathology

AI Cervical Cytology Slide Imaging

Scans cervical screening slides and uses AI to pick out the areas a human should review.

1 products cleared under FDA code QYV, from January 31, 2024 to January 31, 2024. Checked September 25, 2026.

Cervical screening is high volume, and the overwhelming majority of slides are normal. The reviewer is looking for rare abnormal cells among a great many ordinary ones, hundreds of times a week.

This device type scans the slide and uses AI to surface the fields most worth a human eye, so attention lands where it can do something.

It is a good example of AI applied to the attention problem rather than the knowledge problem. Nobody doubts the reviewer can recognize the cells. The difficulty is finding them.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
QYV
FDA name for it
Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Rule number
21 CFR 864.3900
Risk class
Class 2
Medical field
Pathology
The FDA's own wording: 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.

Before You Sign Anything

  • Ask what the reviewer is shown, and whether the rest of the slide remains available.
  • Ask about throughput change, since that is the operational case for this device type.
  • Ask how it fits your screening program rules, which are often national and not negotiable.

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

ProductCompanyClearedFDA record
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” Hologic, Inc. January 31, 2024 DEN210035

Other Pathology Device Types

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.