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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 K241083
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, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received04/19/2024
Decision Date 06/14/2024
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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