Clearance Summary
ArteraAI Breast received FDA 510(k) clearance under submission number K254115, sponsored by Artera, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2026-05-04.
- Submission: K254115
- Applicant / Sponsor: Artera, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3755
- Decision date: 2026-05-04
Classification & Regulation
This clearance is catalogued under FDA product code SHW and 21 CFR 864.3755, within the Pathology review panel as a Class II device.