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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 K243189
Device Name TumorSight Viz
Applicant
SimBioSys, Inc.
320 N Sangamon, Suite 700
Chicago,  IL  60607
Applicant Contact Kimberly Oleson
Correspondent
SimBioSys, Inc.
320 N Sangamon, Suite 700
Chicago,  IL  60607
Correspondent Contact Kimberly Oleson
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/30/2024
Decision Date 10/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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