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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tomographic imager combining emission computed tomography with nuclear magnetic resonance
510(k) Number K163619
Device Name SIGNA PET/MR
Applicant
GE Medical Systems, LLC
3200 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Janice M. Sich
Correspondent
GE Medical Systems, LLC
3200 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Janice M. Sich
Regulation Number892.1200
Classification Product Code
OUO  
Date Received12/22/2016
Decision Date 02/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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