510(k) K254115
K254115 is an FDA 510(k) premarket notification submitted by Artera, Inc. for the device "ArteraAI Breast". The FDA issued a decision of Substantially Equivalent on May 4, 2026. The device falls under product code SHW (Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis), a Class II device regulated under 21 CFR 864.3755. Artera, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2026
- Date Received
- Dec 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
- Device Class
- Class II
- Regulation Number
- 864.3755
- Review Panel
- PA
- Submission Type
A pathology software algorithm device analyzing digital images for breast cancer prognosis is a software intended to analyze digital images acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.