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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 K121095
Device Name DX-D IMAGING PACKAGE
Applicant
AGFA HEALTHCARE N.V.
po box 1927
brevard,  NC  28712
Contact david ledwig
Regulation Number892.1650
Classification Product Code
MQB  
Date Received04/11/2012
Decision Date 08/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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