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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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