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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 K202212
Device Name TruPlan
Applicant
Circle Cardiovascular Imaging, Inc.
Suite 1100 - 800 5th Ave. SW
Calgary,  CA T2P 3T6
Applicant Contact Shirantha Samarappuli
Correspondent
Circle Cardiovascular Imaging, Inc.
Suite 1100 - 800 5th Ave. SW
Calgary,  CA T2P 3T6
Correspondent Contact Shirantha Samarappuli
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/06/2020
Decision Date 02/19/2021
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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