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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 K233728
Device Name SIGNA Champion
Applicant
GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road, Tianjin Airport Economic Area
Tianjin,  CN 300308
Applicant Contact Xinyu Song
Correspondent
GE Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Glen Sabin
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/21/2023
Decision Date 01/19/2024
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
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