510(k) K254115

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 4, 2026

Date Received

December 19, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Pathology Software Algorithm Device Analyzing Digital Images For Breast 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 breast cancer specimens 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.