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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 St., NW
Washington, Dc,  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
Predetermined Change
Control Plan Authorized		 No
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