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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, X-Ray, Electrostatic
510(k) Number K042779
Device Name RADIOTHERAPY SOLUTION BASED ON CR
Applicant
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact JEFFERY A JEDLICKA
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact WILLIAM SAMMONS
Regulation Number892.1630
Classification Product Code
IXK  
Date Received10/06/2004
Decision Date 10/21/2004
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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