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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 K022397
Device Name SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
Applicant
GE MEDICAL SYSTEMS
P.O. 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
P.O. 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/23/2002
Decision Date 08/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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