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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Pathology Image Viewing And Management Software
510(k) Number K243391
Device Name AISight Dx
Applicant
PathAI, Inc.
1325 Boylston Ave.
Suite 10000
Boston,  MA  02215
Applicant Contact Hisani Madison
Correspondent
PathAI, Inc.
1325 Boylston Ave.
Suite 10000
Boston,  MA  02215
Correspondent Contact Carrene Plummer
Regulation Number864.3700
Classification Product Code
QKQ  
Date Received10/31/2024
Decision Date 06/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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