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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
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