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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 K120135
Device Name 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
Original Applicant
TOMTEC IMAGING SYSTEMS, GMBH
edisonstrasse 6
unterschleissheim,  GM d-85716
Original Contact inge scheidt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/17/2012
Decision Date 04/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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