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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 K253779
Device Name SIGNA™ Sprint Select
Applicant
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Xinyu Song
Correspondent
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Xinyu Song
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/26/2025
Decision Date 02/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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