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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, Tomography, Computed
510(k) Number K213725
Device Name CardIQ Suite
Applicant
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Applicant Contact Yonghui Han
Correspondent
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Yonghui Han
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/26/2021
Decision Date 03/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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