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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
Applicant
Surgical Information Sciences, Inc.
60 S. 6th St., Suite 2410
Minneapolis,  MN  55402
Applicant Contact Mark Headrick
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
HAW   LNH  
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
Predetermined Change
Control Plan Authorized		 No
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