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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 K152639
Device Name DR 600
Applicant
Agfa Healthcare N.V.
Septestraat 27
Mortsel,  BE B 2640
Applicant Contact Koren Vervoort
Correspondent
Agfa Healthcare Corp.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact ShaeAnn Cavanagh
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/15/2015
Decision Date 12/11/2015
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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