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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 K141563
Device Name SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
Applicant
RAYENCE CO., LTD
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Applicant Contact DAVE KIM
Correspondent
RAYENCE CO., LTD
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/12/2014
Decision Date 07/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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