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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K214044
Device Name 14HQ901G-B
Applicant
Lg Electronics.Inc
77, Sanho-Daero
Gumi-Si,  KR 39381
Applicant Contact Jinhwan Jun
Correspondent
Gms Consulting
4th Floor, Digital Cube, 34, Sangamsan-Ro
Seoul,  KR 03909
Correspondent Contact DoGyun Im
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/27/2021
Decision Date 02/16/2022
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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