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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 K163331
Device Name Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
Applicant
Ge Medical Systems, LLC
3200 Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Mary A. Mayka
Correspondent
Ge Medical Systems, LLC
3200 Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Mary A. Mayka
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/28/2016
Decision Date 03/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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