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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K103335
Device Name GEM OPTION FOR 1.5 MRI SYSTEMS
Applicant
GE HEALTHCARE
1515 DANNER DR.
AURORA,  OH  44202
Applicant Contact MICHAEL S PRETO
Correspondent
GE HEALTHCARE
1515 DANNER DR.
AURORA,  OH  44202
Correspondent Contact MICHAEL S PRETO
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/15/2010
Decision Date 03/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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