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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
510(k) Number K260023
Device Name TumorSight Risk
Applicant
SimBioSys, Inc.
320 N Sangamon St., Suite 700
Chicago,  IL  60607
Applicant Contact Joseph Peterson
Correspondent
Hogan Lovells US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John Smith
Classification Product Code
SHW  
Date Received01/05/2026
Decision Date 09/25/2026
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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