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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 K931544
Device Name 1.5T EDGE AND 1.0T VISTA SYSTEMS
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact ELAINE K KEELER
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact ELAINE K KEELER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/29/1993
Decision Date 11/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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