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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K222406
Device Name Clarius AI
Applicant
Clarius Mobile Health Corp.
130-2985 Virtual Way
Vancouver,  CA V5M 4X7
Applicant Contact Agatha Szeliga
Correspondent
Clarius Mobile Health Corp.
130-2985 Virtual Way
Vancouver,  CA V5M 4X7
Correspondent Contact Agatha Szeliga
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/09/2022
Decision Date 01/23/2023
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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