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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 K151014
Device Name Aura DR 43C-AG flat panel detector
Applicant
ABYZR CO., LTD
#63-27, GEUMGOK-RO, DONGTAN-MYEON
HWASEONG-SI,  KR 445-811
Applicant Contact JOHN LIM
Correspondent
MTECH GROUP
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/16/2015
Decision Date 07/13/2015
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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