ArteraAI Prostate
by Artera, Inc. De Novo
Active
De Novo DEN240068
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN240068 | Date31 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- De Novo Number
- FDA Product Code
- SFH
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.3755
- Advisory Committee
- Pathology
- FDA Decision
- DENG De Novo granted