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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 K202238
Device Name SIGNA Artist
Applicant
GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road,Tianjin Airport Economic Area
Tianjin,  CN 300308
Applicant Contact Qiang Ding
Correspondent
GE Healthcare (GE Medical System, 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 Received08/07/2020
Decision Date 09/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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