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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
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