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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 K233731
Device Name CardIQ Suite
Applicant
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Applicant Contact Peter Uhlir
Correspondent
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Peter Uhlir
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
QIH  
Date Received11/21/2023
Decision Date 08/01/2024
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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