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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 K201615
Device Name SIGNA 7.0T
Applicant
GE Medical Systems, LLC
3200 Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Brian R. Zielski
Correspondent
GE Medical Systems, LLC
3200 Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Brian R. Zielski
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received06/15/2020
Decision Date 10/15/2020
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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