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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 K112807
Device Name X-RAY VVA
Applicant
Medis Medical Imaging Systems BV
9 Schuttersveld
Leiden,  NL 2316 XG
Applicant Contact D.J.W. BIERHUIZEN
Correspondent
Medis Medical Imaging Systems BV
9 Schuttersveld
Leiden,  NL 2316 XG
Correspondent Contact D.J.W. BIERHUIZEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/27/2011
Decision Date 02/27/2012
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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