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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 K050200
Device Name MAGNETOM TRIO A TIM SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern,  PA  19355 1406
Original Contact ana ladino
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/28/2005
Decision Date 02/28/2005
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
Recalls CDRH Recalls
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