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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 K121948
Device Name CR 10-X DIGITIZER
Applicant
AGFA HEALTHCARE N.V.
SEPTESTRAAT 27
MORTSEL,  BE B 2640
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/03/2012
Decision Date 07/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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