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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241038
Device Name Cardiac CT Function Software Application
Applicant
Circle Cardiovascular Imaging
Suite 1100 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Applicant Contact Sydney Toutant-Lijnse
Correspondent
Circle Cardiovascular Imaging
Suite 1100 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Correspondent Contact Kyle Mayr
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received04/16/2024
Decision Date 06/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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