K-number	K254115
Device name	ArteraAI Breast
Applicant	Artera, Inc.
Product code	SHW
Device class	Class II
Decision date	May 4, 2026
Decision	Substantially Equivalent
Regulation	—

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

ArteraAI Breast is a software-only device that analyzes digital whole slide images of breast tissue specimens to provide 5- and 10-year risk estimates for distant metastasis in adult patients with early-stage HR+/HER2- breast cancer. It combines histopathology image analysis with physician-provided clinical variables (age, tumor size, nodal status) to assist with prognostic risk-based treatment decisions.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to Quality Management System Regulation (QMSR) requirements including ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), 8.5.2 (Corrective action), and 8.5.3 (Preventative action).

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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ArteraAI Breast

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