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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 K232257
Device Name Clarius Bladder AI
Applicant
Clarius Mobile Health Corp.
205-2980 Virtual Way
Vancouver,  CA V5M 4X3
Applicant Contact Agatha Szeliga
Correspondent
Clarius Mobile Health Corp.
205-2980 Virtual Way
Vancouver,  CA V5M 4X3
Correspondent Contact Agatha Szeliga
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/28/2023
Decision Date 11/13/2023
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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