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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
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