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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 K230497
Device Name Bladder AI (AIBV01)
Applicant
Exo Inc
4201 Burton Drive
Santa Clara,  CA  95054
Applicant Contact Jacqueline Murray
Correspondent
Exo Inc
4201 Burton Drive
Santa Clara,  CA  95054
Correspondent Contact Jacqueline Murray
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/24/2023
Decision Date 06/22/2023
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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