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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 K193262
Device Name DR 600 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
MQB  
Date Received11/26/2019
Decision Date 03/09/2020
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
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