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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
510(k) Number K254115
Device Name ArteraAI Breast
Applicant
Artera, Inc.
108 1st St.
Los Altos,  CA  94022
Applicant Contact Candice Bautista
Correspondent
Artera, Inc.
108 1st St.
Los Altos,  CA  94022
Correspondent Contact Madeleine McGill
Classification Product Code
SHW  
Date Received12/19/2025
Decision Date 05/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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