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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 K160914
Device Name sterEOS Workstation
Applicant
Eos Imaging, Inc.
10 Rue Mercoeur
Paris,  FR
Applicant Contact MATHIAS BREUIL
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JOHN J. SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/01/2016
Decision Date 04/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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