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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 K260320
Device Name Lunit INSIGHT MMG (v1.1.10)
Applicant
Lunit, Inc.
4-8f, 374, Gangnam-Daero, Gangnam-Gu
Seoul,  KR 06241
Applicant Contact Sulgue Choi
Correspondent
Lunit, Inc.
4-8f, 374, Gangnam-Daero, Gangnam-Gu
Seoul,  KR 06241
Correspondent Contact Sulgue Choi
Classification Product Code
QDQ  
Date Received01/30/2026
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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