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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 K172435
Device Name Galaxy R Digital Radiography Upgrade
Applicant
Medien International Co, Ltd.
Medien Office Tower, 50, Heungan-Daero 427 Beon-Gil Dongan-G
Anyang-Si,  KR 435-040
Applicant Contact Jae Hyun Lee
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/11/2017
Decision Date 10/13/2017
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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