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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K832603
Device Name CURIX CAPACITY FILM CENTER
Applicant
Agfa-Gevaert, Inc.
Tegernseer Landstrasse 161
8000 Mucrchon 90
West Germany,  DE
Correspondent
Agfa-Gevaert, Inc.
Tegernseer Landstrasse 161
8000 Mucrchon 90
West Germany,  DE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received07/29/1983
Decision Date 09/29/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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