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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 K253796
Device Name Lunit INSIGHT DBT (V1.2)
Applicant
Lunit, Inc.
4-8f, 374, Gangnam-Daero, Gangnam-Gu
Seoul,  KR
Applicant Contact Hyeseung Yoo
Correspondent
Lunit, Inc.
4-8f, 374, Gangnam-Daero, Gangnam-Gu
Seoul,  KR
Correspondent Contact Sulgue Choi
Classification Product Code
QDQ  
Date Received11/28/2025
Decision Date 03/26/2026
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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