FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ArteraAI Prostate
K Number: DEN240068
·
Decision Jul 31, 2025
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
2
Review Days
248
Basic Information
- Device Name
- ArteraAI Prostate
- K Number
- DEN240068
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 864.3755
- Medical Specialty
- Pathology
- Decision
- Unknown
- Applicant
- Artera, Inc.
- Date Received
- November 25, 2024
- Decision Date
- July 31, 2025
- Product Code
- SFH
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SFH | Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis | FDA class 2 | Pathology |
Other Clearances by Artera, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254115 | ArteraAI Breast | May 4, 2026 | Substantially Equivalent |