DEN240068 is an FDA 510(k) submission for the ArteraAI Prostate. This device is classified as a Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis (Class II - Special Controls, product code SFH).
Submitted by Artera, Inc. (Los Altos, US). The FDA issued a Not Cleared (DENG) decision on July 31, 2025.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3755. A Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis Is A Software Intended To Analyze Scanned Whole Slide Images (wsis) From Prostate Biopsies Prepared From Formalin Fixed Paraffin-embedded (ffpe) Tissue And Stained Using Hematoxylin & Eosin (h&e) Stains. 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..
| 510(k) Number | DEN240068 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 25, 2024 |
| Decision Date | July 31, 2025 |
| Days to Decision | 248 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | SFH - Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.3755 |
| Definition | A Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis Is A Software Intended To Analyze Scanned Whole Slide Images (wsis) From Prostate Biopsies Prepared From Formalin Fixed Paraffin-embedded (ffpe) Tissue And Stained Using Hematoxylin & Eosin (h&e) Stains. 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. |