Devices · Artera, Inc.

ArteraAI Breast

Artera, Inc. is listed for ArteraAI Breast (K254115). The FDA list gives May 4, 2026 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SHW as “Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254115

Official FDA database record

Date of final decision

May 4, 2026

Company on the FDA list

Artera, Inc.

Lead panel

Pathology

Primary product code

SHW

openFDA device name for the code

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

Device class

2

Regulation number

864.3755

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Statement