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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 K183231
Device Name SIGNA Premier
GE Medical Systems, LLC
3200 Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Brian R. Zielski
GE Medical Systems, LLC
3200 N. Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Brian R. Zielski
Regulation Number892.1000
Classification Product Code
Subsequent Product Codes
Date Received11/20/2018
Decision Date 01/18/2019
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