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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K243863
Device Name Opulus™ Lymphoma Precision
Applicant
Roche Molecular Systems, Inc.
2881 Scott Blvd.
Santa Clara,  CA  95050
Applicant Contact Aarti Shukla
Correspondent
Roche Molecular Systems, Inc.
2881 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact Aarti Shukla
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/17/2024
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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