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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 K183286
Device Name 17HK701G-W
Applicant
Lg Electronics.Inc
222, Lg-Ro,
Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
Lg Electronics.Inc
222, Lg-Ro,
Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/26/2018
Decision Date 12/07/2018
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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