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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K183019
Device Name SIS Software version 3.3.0
Applicant
Surgical Information Sciences, Inc.
50 South 6th Street, Suite 1310
Minneapolis,  MN  55402
Applicant Contact Ann Quinlan-Smith
Correspondent
Hogan Lovells US LLP
1735 Market Street, 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
HAW   LNH  
Date Received10/31/2018
Decision Date 03/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT02902328
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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