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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K191188
Device Name ASHK100G
Applicant
Lg Electronics
222, Lg-Ro, Cheongho-Ri
Jinwi-Myeon Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
Lg Electronics
222, Lg-Ro, Cheongho-Ri
Jinwi-Myeon Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/03/2019
Decision Date 05/30/2019
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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