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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 K041701
Device Name AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
Applicant
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact JEFFERY A JEDLICKA
Correspondent
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact JEFFERY A JEDLICKA
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/22/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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