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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K113511
Model 2011
Device Name ECHOSTAR SPICA 1.5T MR SYSTEM
Original Applicant
ALLTECH MEDICAL SYSTEMS AMERICA, INC.
6551 cochran road
solon,  OH  44139
Original Contact michaeleen dom
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/28/2011
Decision Date 05/02/2012
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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