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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 K192426
Device Name Signa Voyager, Signa Voyager Quantum
Applicant
GE Healthcare(Tianjin) Company Limited
No. 266 Jinjsan Road, Tianjin Airport Economic Area
Tianjin,  CN 300308
Applicant Contact Yuan Ma
Correspondent
GE Healthcare(Tianjin) Company Limited
No. 266 Jinjsan Road, Tianjin Airport Economic Area
Tianjin,  CN 300308
Correspondent Contact Yuan Ma
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received09/05/2019
Decision Date 10/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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