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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 K191864
Device Name 21HK512D
Applicant
Lg Electronics.Inc
222, Lg-Ro, Cheongho-Ri, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
Lg Electronics.Inc
222, Lg-Ro, Cheongho-Ri, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/12/2019
Decision Date 12/05/2019
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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