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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 K013858
Device Name INFINION 0.6T MR IMAGING SYSTEM
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
highland heights,  OH  44143
Original Contact duane c praschan
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/21/2001
Decision Date 01/22/2002
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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