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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 Street 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
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