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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K160279
Device Name ANYVIEW-500R Fluoroscopic Mobile X-Ray System
Applicant
Ecotron Co., Ltd.
Rm.504, Hanshin It Tower Ii, 47, Digital-Ro 9-Gil
Geumcheon-Gu
Seoul,  KR 153-712
Applicant Contact Sang Bong Lee
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received02/02/2016
Decision Date 10/14/2016
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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