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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
Predetermined Change
Control Plan Authorized		 No
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