# K260023: TumorSight Risk

- Pathway: 510(k) (Traditional)
- Applicant: SimBioSys, Inc.
- Decided: Sep 25, 2026 after 263 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
Longest line of descent: 1 generation back to K254115 (2026). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K254115: ArteraAI Breast, Artera, Inc. (2026). Cleared while this submission was under review Summary page 5.

## Indications for use
TumorSight Risk is an artificial intelligence based software only device that analyzes data from previously diagnosed invasive breast cancer patients to assess the risk of recurrence. TumorSight Risk utilizes the following data: age, race, cancer stage, nodal status, and grade, combined with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) data to generate 5- and 10-year risks of breast cancer recurrence and a proprietary prognostic score. TumorSight Risk is intended for use in adult women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-), lymph node negative (N0) or positive (N1), Stage I-IIIA breast cancer to inform a physician in prognostic risk-based decisions in conjunction with other relevant clinicopathological factors.

Source page: https://510kreport.com/device/K260023
Methodology: https://510kreport.com/methodology