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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 K223789
Device Name 21HQ513D
Applicant
LG Electronics Inc.
168, Suchul-daero
Gumi-si,  KR 39368
Applicant Contact Jinhwan Jun
Correspondent
LG Electronics
222, LG-ro, Jinwi-myeon
Pyeongtaek-si,  KR 17709
Correspondent Contact Daseul An
Regulation Number892.2050
Classification Product Code
PGY  
Date Received12/19/2022
Decision Date 01/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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