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Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

FDA product code SHW · 2 cleared devices

Class 2 Pathology
Regulation
21 CFR 864.3755
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-05-04 – 2026-09-25

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.

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