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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 K213603
Device Name SIGNA Artist Evo
Applicant
GE Healthcare(Tianjin) Company Limited
No. 266 Jinjsan Road, Tianjin Airport Economic Area
Tianjin,  CN 300308
Applicant Contact Qiang Ding
Correspondent
GE Healthcare (GE Medical Systems, LLC)
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Glen Sabin
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/15/2021
Decision Date 02/11/2022
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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