De Novo
DEN240068: ArteraAI Prostate
FDA De Novo · artera inc. · decided Jul 31, 2025
Key facts
| De Novo number | DEN240068 |
|---|---|
| Device name | ArteraAI Prostate |
| Applicant | artera inc. |
| Product code | SFH |
| Date received | Nov 25, 2024 |
| Decision date | Jul 31, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Pathology |
| FEI number | 3029787717 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None 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: