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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, Fluoroscopic, Image-Intensified
510(k) Number K180589
Device Name DR 800 with MUSICA Dynamic
Applicant
Agfa HealthCare N.V.
Septestraat 27
Mortsel,  BE b-2640
Applicant Contact Wim Govaerts
Correspondent
Agfa HealthCare Corporation
10 South Academy Street
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/06/2018
Decision Date 04/05/2018
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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