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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
Predetermined Change
Control Plan Authorized		 No
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