Device type

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

Product code SHW · Class II · 21 CFR 864.3755 · Pathology

A pathology software algorithm device analyzing digital images for breast cancer prognosis is a software intended to analyze digital images acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). 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.

FDA classification database