Product code SFH— Pathology
ArteraAI Prostate
- Classification name
- Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
- Device class
- Class 2
- Regulation
- 21 CFR 864.3755
- Advisory panel
- Pathology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SFH
FDA has cleared device under product code SFH, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SFH
Recent clearances under product code SFH
Data sourced from openFDA. This site is unofficial and independent of the FDA.