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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 K222593
Device Name TruPlan Computed Tomography (CT) Imaging Software
Applicant
Circle Cardiovascular Imaging, Inc.
Suite 110 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Applicant Contact Sydney Toutant
Correspondent
Circle Cardiovascular Imaging, Inc.
Suite 110 - 800 5th Ave SW
Calgary,  CA T2P 3T6
Correspondent Contact Sydney Toutant
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/26/2022
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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