510(k) DEN240068
- Device
- ArteraAI Prostate
- Applicant
- Artera, Inc.
- 510(k) number
- DEN240068
- Product code
- SFH
- Decision
- Unknown (DENG)
- Decision date
- 2025-07-31
- Date received
- 2024-11-25
- Regulation
- 864.3755
- Classification name
- Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Candice Bautista-Biddle
- Address
- 108 1st St. Los Altos CA US 94022 94022
FDA Registration Numbers
- 3029787717
Source Documents
510(k) summary PDF not indicated by FDA