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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 K122173
Device Name DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
Applicant
RAYENCE CO., LTD
12946 kimberley ln
houston,  TX  77079
Contact dave kim
Regulation Number892.1650
Classification Product Code
MQB  
Date Received07/23/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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