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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, Mobile
510(k) Number K191884
Device Name DR 100s
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 Number892.1720
Classification Product Code
IZL  
Date Received07/15/2019
Decision Date 08/09/2019
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
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