# K254115: ArteraAI Breast

- Pathway: 510(k) (Traditional)
- Applicant: Artera, Inc.
- Decided: May 4, 2026 after 136 days
- Product code: SHW (Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis)
- Device class: 2
- Regulation: 21 CFR 864.3755
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K260023: TumorSight Risk (2026), 0 descendants of its own

## Indications for use
ArteraAI Breast is a software only device intended to analyze scanned histopathology whole slide image (WSI) from treatment-naïve breast resection specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. Additional inputs to ArteraAI Breast include the following physician-provided clinical variables: ● Age ● Tumor size ● Nodal status ArteraAI Breast provides 5- and 10-year risks of distant metastasis and ArteraAI risk score for adult patients with HR+/HER2-, N0 or N1, early-stage invasive breast cancer without clinically or pathologically defined metastases after surgical tumor resection and who are candidates for standard of care adjuvant therapy. ArteraAI Breast is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. ArteraAI Breast is intended to utilize WSIs acquired from FDA-cleared interoperable scanners and file formats that have been validated for use with this device.

Source page: https://510kreport.com/device/K254115
Methodology: https://510kreport.com/methodology