FDA Product Code SFH: Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
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.
Leading manufacturers include Artera, Inc..
FDA 510(k) Cleared Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis Devices (Product Code SFH)
About Product Code SFH - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFH since 2025, with 0 receiving FDA clearance (average review time: 248 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFH devices are reviewed by the Pathology panel. Browse all Pathology devices →