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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
Agfa HealthCare N.V.
Septestraat 27
Mortsel,  BE b-2640
Applicant Contact Wim Govaerts
Agfa HealthCare Corporation
10 South Academy Street
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.1650
Classification Product Code
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
Recalls CDRH Recalls