De Novo · Granted
Granted“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Granted on Jan 31, 2024 as a new device type through De Novo after an 887-day review.
- Decided
- Jan 31, 2024
- Review
- 887 days
- Class
- Class II
- Product code
- QYV
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QYV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QYV devicesQYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QYV
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QYV
Too few QYV 510(k)s in any year since 2007 to give a median.
Recalls per year · QYV
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QYV
No MAUDE report names QYV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (226 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210035 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210035: “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210035
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026