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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 K885047
Device Name VISTA MR 2055 HP SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact JANET E MINNIS
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact JANET E MINNIS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/06/1988
Decision Date 03/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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