510(k) DEN240068

ArteraAI Prostate by Artera, Inc. — Product Code SFH

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: July 31, 2025
Date Received: November 25, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
Device Class: Class II
Regulation Number: 864.3755
Review Panel: PA
Submission Type

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.