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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 K253780
Device Name SIGNA™ Bolt
Applicant
Ge Medical Systems, LLC
3200 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Emily Fang
Correspondent
Ge Medical Systems, LLC
3200 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Emily Fang
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/26/2025
Decision Date 02/06/2026
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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