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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K232661
Device Name Myocardial Strain Software Application
Applicant
Circle Cardiovascular Imaging
Suite 110 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Applicant Contact Sydney Toutant
Correspondent
Circle Cardiovascular Imaging
Suite 110 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Correspondent Contact Sydney Toutant
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/31/2023
Decision Date 12/07/2023
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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