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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
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