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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 K964626
Device Name EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 avion park dr.
highland heights,  OH  44143
Original Contact elaine k keeler
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/19/1996
Decision Date 02/10/1997
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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