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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K790273
Device Name MAMMOGRAPHY SYSTEM AND CASSETTE
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 Number892.1710
Classification Product Code
IZH  
Date Received02/08/1979
Decision Date 03/21/1979
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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