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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 K052293
Device Name GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
Applicant
GE MEDICAL SYSTEMS, LLC
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A KROGER, PH.D.
Correspondent
GE MEDICAL SYSTEMS, LLC
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY A KROGER, PH.D.
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/23/2005
Decision Date 09/21/2005
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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