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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 K170172
Device Name UNiD Spine Analyzer
Applicant
MEDICREA INTERNATIONAL
5389 Route de Strasbourg-Vancia
Rillieux La Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Hogan Lovells US LLP
5389 Route de Strasbourg - Vancia
Rillieux La Pape,  FR
Correspondent Contact David Ryan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/19/2017
Decision Date 05/24/2017
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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