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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 K162722
Device Name HyperSense
Applicant
GE MEDICAL SYSTEMS, LLC
3200 GRANDVIEW BLVD
WAUKESHA,  WI  53188
Applicant Contact GLEN SABIN
Correspondent
GE MEDICAL SYSTEMS, LLC
3200 GRANDVIEW BLVD
WAUKESHA,  WI  53188
Correspondent Contact GLEN SABIN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/29/2016
Decision Date 04/20/2017
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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