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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, Tomographic
510(k) Number K183275
Device Name DR 800 with Tomosynthesis
Applicant
Agfa N.V.
Septestraat 27
Mortsel,  BE B-2640
Applicant Contact Wim Govaerts
Correspondent
Agfa US Corp.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Code
JAA  
Date Received11/23/2018
Decision Date 02/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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