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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
Applicant
AGFA HEALTHCARE N.V.
PO BOX 1927
BREVARD,  NC  28712
Applicant Contact DAVID LEDWIG
Correspondent
AGFA HEALTHCARE N.V.
PO BOX 1927
BREVARD,  NC  28712
Correspondent 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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