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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 K232202
Device Name Aperio GT 450 DX
Applicant
Leica Biosystems Imaging, Inc.
1360 Park Center Drive
Vista,  CA  92081
Applicant Contact April Komplin
Correspondent
Leica Biosystems Imaging, Inc.
1360 Park Center Drive
Vista,  CA  92081
Correspondent Contact April Komplin
Regulation Number864.3700
Classification Product Code
PSY  
Date Received07/25/2023
Decision Date 04/16/2024
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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