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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 K253561
Device Name Aperio iQC DX Software
Applicant
Leica Biosystems Imaging, Inc.
1360 Park Center Dr.
Vista,  CA  92081
Applicant Contact Tamatha Melton
Correspondent
Leica Biosystems Imaging, Inc.
1360 Park Center Dr.
Vista,  CA  92081
Correspondent Contact Tamatha Melton
Regulation Number864.3700
Classification Product Code
QKQ  
Subsequent Product Code
PSY  
Date Received11/17/2025
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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