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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 K230977
Device Name SIS System
Applicant
Surgical Information Sciences, Inc.
5201 Eden Avenue, Suite 300
Edina,  MN  55436
Applicant Contact Ann Quinlan-Smith
Correspondent
Hogan Lovells, US LLP
1735 Market Street, 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kelliann H. Payne
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received04/05/2023
Decision Date 05/02/2023
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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