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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 K240697
Device Name See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
Applicant
See-Mode Technologies Pte, Ltd.
32 Carpenter St., #03-01
Singapore,  SG 059911
Applicant Contact Sadaf Monajemi
Correspondent
See-Mode Technologies Pte, Ltd.
32 Carpenter St., #03-01
Singapore,  SG 059911
Correspondent Contact Sadaf Monajemi
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received03/14/2024
Decision Date 09/09/2024
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		 No
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