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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 K162990
Device Name Optima XR240amx
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Chris Paulik
Correspondent
GE Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Chris Paulik
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received10/27/2016
Decision Date 11/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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