ArteraAI Breast is an AI-enabled medical device from Artera, Inc. that the U.S. FDA cleared through 510(k) K254115 on May 4, 2026. Its lead review panel is Pathology and its primary product code is SHW (Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis).
See also all FDA AI clearances in 2026.
Key facts
| Submission number | K254115 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Artera, Inc. |
| Lead review panel | Pathology |
| Primary product code | SHW — Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis |
| Applicant (openFDA) | Artera, Inc. |
| Applicant location | Los Altos, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.3755 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. ArteraAI Breast went through this pathway (K254115).
openFDA lists it as a Class 2 device under 21 CFR 864.3755. Class II devices are moderate risk and are subject to general and special controls.
Product code SHW covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Artera, Inc. has 2 AI-enabled devices on the list, and the Pathology panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.