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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K232985
Device Name 24HR513C
Applicant
Lg Electronics.Inc
168, Suchul-Daero
Gumi-Si,  KR 39368
Applicant Contact Jinhwan Jun
Correspondent
Gms Consulting
#B-612, 66 Chengcho-Ro
Gyeonggi-Do,  KR 10543
Correspondent Contact JongHyun Kim
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/22/2023
Decision Date 12/11/2023
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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