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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 K153003
Device Name SIGNA Pioneer
Applicant
GE HEALTHCARE
3200 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Andrew Menden
Correspondent
GE HEALTHCARE
3200 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Andrew Menden
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received10/13/2015
Decision Date 10/27/2015
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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