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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K150193
Device Name Customer Remote Console (CRC)
Applicant
GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
waukesha,  WI  53188
Applicant Contact john w. jaeckle
Correspondent
GE HEALTHCARE
9900 Innovation Drive
wauwatosa,  WI  53226
Correspondent Contact elizabeth mathew
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/28/2015
Decision Date 03/24/2015
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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