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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 K083421
Device Name MR-TOUCH OPTION
Applicant
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact Daniel Biank
Correspondent
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact Daniel Biank
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/19/2008
Decision Date 07/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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