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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 K242652
Device Name Lunit INSIGHT DBT v1.1
Applicant
Lunit Inc.
4-8 F, 374, Gangnam-daero, Gangnam-gu
Seoul,  KR 06241
Applicant Contact Suhyoung Bahk
Correspondent
Lunit Inc.
4-8 F, 374, Gangnam-daero, Gangnam-gu
Seoul,  KR 06241
Correspondent Contact Suhyoung Bahk
Classification Product Code
QDQ  
Date Received09/04/2024
Decision Date 10/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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