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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, mobile
510(k) Number K103597
Device Name DX-D 100
Applicant
AGFA HEALTHCARE N.V.
10 S ACADEMY STREET
GREENVILLE,  SC  29601
Applicant Contact PHIL CUSCUNA
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/08/2010
Decision Date 01/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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