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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, tomography, computed, emission
510(k) Number K161574
Device Name Discovery MI
Applicant
GE Medical Systems, L.L.C.
3000 N Grandview Blvd
waukesha,  WI  53188
Applicant Contact helen peng
Correspondent
GE Medical Systems, L.L.C.
3000 N Grandview Blvd
waukesha,  WI  53188
Correspondent Contact helen peng
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/07/2016
Decision Date 08/11/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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