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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
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