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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 K213998
Device Name cvi42 Auto Imaging Software Application
Applicant
Circle Cardiovascular Imaging Inc
Suite 1100 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Applicant Contact Sydney Toutant
Correspondent
Circle Cardiovascular Imaging Inc
Suite 1100 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Correspondent Contact Sydney Toutant
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received12/21/2021
Decision Date 07/28/2022
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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