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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 Triage And Notification Software
510(k) Number K241480
Device Name JBS-LVO
Applicant
JLK, Inc.
Jlk Tower, 5, Teheran-Ro 33-Gil
Gangnam-Gu
Seoul,  KR 06141
Applicant Contact Kim Dongmin
Correspondent
Hogan Lovells
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received05/24/2024
Decision Date 09/27/2024
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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