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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 K000159
Device Name AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
Applicant
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Agfa Corp.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.1630
Classification Product Code
IXK  
Date Received01/19/2000
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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