ArteraAI Prostate
FDA 510(k) clearance DEN240068 · decided 2025-07-31
Clearance details
- K-number
- DEN240068
- Device name
- ArteraAI Prostate
- Applicant
- Artera, Inc.
- Decision
- Unknown
- Date received
- 2024-11-25
- Decision date
- 2025-07-31
- Days to decision
- 248 days
- Clearance type
- Direct
- Product code
- SFH
- Device class
- 2
- Regulation number
- 864.3755
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.