# DEN240068: ArteraAI Prostate

- Pathway: De Novo (Direct)
- Applicant: Artera, Inc.
- Decided: Jul 31, 2025 after 248 days
- Product code: SFH (Pathology Software Algorithm Device Analyzing Digital Images For Prostate 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from treatment-naïve prostate core needle biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. ArteraAI Prostate provides 10-year risks of distant metastasis and prostate cancer specific mortality and is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors in non-metastatic prostate cancer patients. ArteraAI Prostate is intended for males 55 years of age or older without clinically or pathologically defined metastases, and who are candidates for curative intent management (surgery, radiation therapy with or without systemic therapy, or active surveillance). ArteraAI Prostate is intended to utilize WSIs acquired from an FDA-cleared interoperable scanner with which ArteraAI Prostate has been authorized for use or a 510(k)-cleared scanner that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional interoperable scanners.

Source page: https://510kreport.com/device/DEN240068
Methodology: https://510kreport.com/methodology