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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 K250379
Device Name SIGNA Prime Elite
Applicant
GE Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Glen Sabin
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 Received02/11/2025
Decision Date 03/17/2025
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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