DeviceClearance

Product code SHW— Pathology

ArteraAI Breast

Classification name
Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
Device class
Class 2
Regulation
21 CFR 864.3755
Advisory panel
Pathology
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SHW under 21 CFR 864.3755, via openFDA

Market context for product code SHW

FDA has cleared 2 devices under product code SHW, all in 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHW

Recent clearances under product code SHW

Data sourced from openFDA. This site is unofficial and independent of the FDA.