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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 K223523
Device Name Sonic DL
Applicant
GE Medical Systems,LLC (GE Healthcare)
3200 N Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Glen Sabin
Correspondent
GE Medical Systems,LLC (GE Healthcare)
3200 N Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Glen Sabin
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/23/2022
Decision Date 05/30/2023
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
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