Pathology Software Algorithm Device Analyzing Digital Images for Prostate Cancer Prognosis
Clearances per Year
1
2025
What the FDA Actually Signed Off On
- FDA product code
- SFH
- FDA name for it
- Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis
- Rule number
- 21 CFR 864.3755
- Risk class
- Class 2
- Medical field
- Pathology
The FDA's own wording: A pathology software algorithm device analyzing digital images for prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| ArteraAI Prostate | Artera, Inc. | July 31, 2025 | DEN240068 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.