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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 K192304
Device Name SIS Software Version 3.6.0
Surgical Information Sciences, Inc.
10405 6th Avenue North, Suite 110
Plymouth,  MN  55441
Applicant Contact Ann Quinlan-Smith
Hogan Lovells, US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number892.2050
Classification Product Code
Date Received08/23/2019
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No