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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
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 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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