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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K250221
Device Name StrokeSENS ASPECTS Software Application
Applicant
Circle Cardiovascular Imaging, Inc.
Suite 1800, 707 8 Ave. SW
Calgary,  CA T2P 1H5
Applicant Contact Kyle Mayr
Correspondent
Circle Cardiovascular Imaging, Inc.
Suite 1800, 707 8 Ave. SW
Calgary,  CA T2P 1H5
Correspondent Contact Kyle Mayr
Regulation Number892.2060
Classification Product Code
POK  
Date Received01/24/2025
Decision Date 07/01/2025
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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