ArteraAI Breast— 510(k) K254115

Substantially Equivalent

Artera, Inc.

FDA 510(k) clearance K254115 for ArteraAI Breast, Substantially Equivalent on 2026-05-04. Applicant: Artera, Inc..

Clearance details

Applicant: Artera, Inc.
Product code: Code SHW
Advisory panel: Pathology
Date received: 2025-12-19
Decision date: 2026-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos, CA, US

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