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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 K223439
Device Name SIGNA Victor
Applicant
GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road,Tianjin Airport Economic Area
Tianjin,  CN 300308
Applicant Contact Huande Li
Correspondent
GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road,Tianjin Airport Economic Area
Tianjin,  CN 300308
Correspondent Contact Huande Li
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/14/2022
Decision Date 02/13/2023
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
Recalls CDRH Recalls
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