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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 K211980
Device Name SIGNA Prime
Applicant
GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road, Tianjin Airport Economic Area
Tianjin,  CN 300308
Applicant Contact Huande Li
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  
Date Received06/25/2021
Decision Date 01/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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