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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 K081963
Device Name AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
Applicant
Agfa Healthcare Corporation
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact JEFFERY A JEDLICKA
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/10/2008
Decision Date 07/25/2008
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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