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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 K222895
Device Name DynamicIQ
Applicant
GE Medical Systems SCS
283, rue de la Miniere
Buc,  FR 78530
Applicant Contact Tong Zhao
Correspondent
GE Medical Systems SCS
283, rue de la Miniere
Buc,  FR 78530
Correspondent Contact Tong Zhao
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received09/23/2022
Decision Date 11/22/2022
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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