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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K233955
Device Name Clarius OB 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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
QIH  
Date Received12/15/2023
Decision Date 06/14/2024
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		 Yes
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