FDA PRODUCT CODE · CLASS II
SHW — Pathology Software Algorithm Device Analyzing Digital Images For Breast 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 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.
Recent clearances
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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