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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K210982
Device Name AMX Navigate
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Martha Kamrow
Correspondent
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Martha Kamrow
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received04/01/2021
Decision Date 04/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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