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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K260303
Device Name See-Mode Augmented Reporting Tool, Breast (SMART-B)
Applicant
See-Mode Technologies Pty, Ltd.
3/162 Collins St.
Melbourne,  AU 3000
Applicant Contact Sadaf Monajemi
Correspondent
See-Mode Technologies Pty, Ltd.
3/162 Collins St.
Melbourne,  AU 3000
Correspondent Contact Sadaf Monajemi
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received01/30/2026
Decision Date 07/28/2026
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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