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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
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