De Novo
DEN210035: “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
FDA De Novo · hologic inc. · decided Jan 31, 2024
Key facts
| De Novo number | DEN210035 |
|---|---|
| Device name | “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” |
| Applicant | hologic inc. |
| Product code | QYV |
| Date received | Aug 27, 2021 |
| Decision date | Jan 31, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Pathology |
| FEI number | 1000120743 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: