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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 Prioritization Software For Lesions
510(k) Number K211733
Device Name Lunit INSIGHT CXR Triage
Applicant
Lunit, Inc.
15th Floor, 27 Teheran-Ro 2-Gil
Seoul,  KR 06241
Applicant Contact Seulhee Jung
Correspondent
Hogan Lovells
Columbia Square 555 Thirteenth St., Northwest
Washington,  DC  20004
Correspondent Contact Colin S. Jacob
Regulation Number892.2080
Classification Product Code
QFM  
Date Received06/04/2021
Decision Date 11/10/2021
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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