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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K161368
Device Name DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
Applicant
Agfa Healthcare N.V.
Septestraat 27
Mortsel,  BE B-2640
Applicant Contact Koen Vervoort
Correspondent
Agfa Healthcare
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/17/2016
Decision Date 09/22/2016
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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