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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 K232346
Device Name Digital Expert Access with Remote Scanning
Applicant
GE Healthcare
500 W. Monroe Street
Chicago,  IL  60661
Applicant Contact Allena Holzworth
Correspondent
GE Healthcare
500 W. Monroe Street
Chicago,  IL  60661
Correspondent Contact Allena Holzworth
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received08/04/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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