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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 K063421
Device Name DX-SI
Applicant
AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Applicant Contact JEFFERY A JEDLICKA
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
KPR  
Date Received11/13/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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