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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name whole slide imaging system
510(k) Number K190332
Device Name Aperio AT2 DX System
Applicant
Leica Biosystems Imaging, Inc.
1360 Park Center Dr.
Vista,  CA  92081
Applicant Contact Christine Kishi
Correspondent
Leica Biosystems Imaging, Inc.
1360 Park Center Dr.
Vista,  CA  92081
Correspondent Contact Christine Kishi
Regulation Number864.3700
Classification Product Code
PSY  
Date Received02/14/2019
Decision Date 05/20/2019
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
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