1 device · 1 company · 2026
Product code SHW: Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
1 device under product code SHW, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis. 21 CFR 864.3755, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| ArteraAI BreastK254115 · 510(k) | Artera, Inc. | Pathology | database entry |
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