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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K212261
Device Name StrokeSENS LVO
Applicant
Circle Neurovascular Imaging, Inc.
Suite 1100 - 800 5th Ave. SW
Calgary,  CA T2P 3T6
Applicant Contact Kyle Mayr
Correspondent
Circle Cardiovascular Imaging, Inc.
800 5th Ave. SW
Suite 1100
Calgary,  CA T2P 3T6
Correspondent Contact Kyle Mayr
Regulation Number892.2080
Classification Product Code
QAS  
Date Received07/20/2021
Decision Date 10/14/2021
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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