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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 K211678
Device Name Lunit INSIGHT MMG
Applicant
Lunit Inc.
15 Floor, 27 Teheran-ro-2-gil, Gangnam-gu,
Seoul,  KR 06241
Applicant Contact Joohee Lee
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John Smith
Classification Product Code
QDQ  
Date Received06/01/2021
Decision Date 11/17/2021
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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