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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 K121676
Device Name 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
Applicant
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact SHASHIDHAR CS
Correspondent
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact SHASHIDHAR CS
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received06/07/2012
Decision Date 09/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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