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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 K231130
Device Name TumorSight Viz
Applicant
SimBioSys, Inc.
180 North Lasalle Street, Suite 3250
Chicago,  IL  60601
Applicant Contact Tricia Carrigan
Correspondent
Hogan & Lovells US LPP
1735 Market Street
Floor 23
Philadelphia,  PA  19103
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/20/2023
Decision Date 12/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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