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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 K232879
Device Name Roche Digital Pathology Dx (VENTANA DP 200)
Applicant
Ventana Medical Systems, Inc.
(Ventana, VMSI, Roche Tissue Diagnostics, RTD)
1910 E. Innovation Park Drive
Tucson,  AZ  85755
Applicant Contact Cameron Smith
Correspondent
Ventana Medical Systems, Inc.
(Ventana, VMSI, Roche Tissue Diagnostics, RTD)
1910 E. Innovation Park Drive
Tucson,  AZ  85755
Correspondent Contact Cameron Smith
Regulation Number864.3700
Classification Product Code
PSY  
Date Received09/18/2023
Decision Date 06/14/2024
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
Predetermined Change
Control Plan Authorized		 No
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