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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
Applicant Contact david ledwig
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/11/2012
Decision Date 08/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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