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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 K211846
Device Name Discovery MI Gen2
Applicant
GE Medical Systems, LLC.
3000 North Grandview Blvd
waukesha,  WI  53188
Applicant Contact laura turner
Correspondent
GE Medical Systems, LLC.
3000 North Grandview Blvd
waukesha,  WI  53188
Correspondent Contact laura turner
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/15/2021
Decision Date 08/20/2021
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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