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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 K113630
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
Original Applicant
RAYENCE CO., LTD
8310 buffalo speedway
houston,  TX  77025
Original Contact dave kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/08/2011
Decision Date 12/29/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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