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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 K162830
Device Name SIS Software
Surgical Information Sciences, Inc.
60 South 6th Street, Suite 2410
Minneapolis,  MN  55402
Applicant Contact Mark Headrick
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number892.2050
Classification Product Code
Subsequent Product Codes
Date Received10/07/2016
Decision Date 02/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No