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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 K896647
Device Name GYROVIEW HR HIGH RESOLUTION WORKSTATION
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Applicant Contact WILLIAM MCMAHON
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Correspondent Contact WILLIAM MCMAHON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/24/1989
Decision Date 12/21/1989
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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