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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 K122736
Device Name DX-D IMAGING PACKAGE
Original Applicant
AGFA HEALTHCARE N.V.
po box 1927
brevard,  NC  28712
Original Contact david ledwig
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/19/2012
Decision Date 03/11/2013
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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