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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 K231470
Device Name Lunit INSIGHT DBT
Applicant
Lunit Inc.
4-8 F, 374 Gangnam-daero, Gangnam-gu
Seoul,  KR 06241
Applicant Contact Hyung Tak Han
Correspondent
Lunit Inc.
4-8 F, 374 Gangnam-daero, Gangnam-gu
Seoul,  KR 06241
Correspondent Contact Hyung Tak Han
Classification Product Code
QDQ  
Date Received05/22/2023
Decision Date 11/06/2023
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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