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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 K041476
Device Name GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
Applicant
GE MEDICAL SYSTEMS, LLC
PO BOX 414
MILWAUKEE,  WI  53188
Applicant Contact LARRY A KROGER PH.D.
Correspondent
GE MEDICAL SYSTEMS, LLC
PO BOX 414
MILWAUKEE,  WI  53188
Correspondent Contact LARRY A KROGER PH.D.
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/03/2004
Decision Date 06/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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