# DEN210035: “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

- Pathway: De Novo (Direct)
- Applicant: Hologic, Inc.
- Decided: Jan 31, 2024 after 887 days
- Product code: QYV (Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm)
- Device class: 2
- Regulation: 21 CFR 864.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Genius Digital Diagnostics System with the Genius Cervical AI algorithm includes the Genius Digital Imager, Genius Image Management Server (IMS), the Genius Review Station, and the Genius Cervical AI algorithm. The Genius Digital Diagnostics System with the Genius Cervical AI algorithm is intended for the creation and viewing of digital images of scanned ThinPrep Pap Test glass slides. Objects of interest selected by the Genius Cervical AI algorithm from the scanned digital image are presented in a gallery format next to the image of the whole cell spot on the Genius Review Station for review and interpretation. The Genius Digital Diagnostics System with the Genius Cervical AI algorithm is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions) and carcinoma, as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology1. After digital review with the Genius Cervical AI algorithm, if there is uncertainty in the diagnosis, then direct examination of the glass slide by light microscopy should be performed. Digital images from the Genius Digital Diagnostics System with the Genius Cervical AI algorithm should be interpreted by qualified cytologists and pathologists in conjunction with the patient’s screening history, other risk factors, and professional guidelines which guide patient management.

Source page: https://510kreport.com/device/DEN210035
Methodology: https://510kreport.com/methodology