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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K111324
Device Name CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
Applicant
AGFA HEALTHCARE N.V.
10 S ACADEMY STREET
GREENVILLE,  SC  29601
Applicant Contact PHIL CUSCUNA
Correspondent
AGFA HEALTHCARE N.V.
10 S ACADEMY STREET
GREENVILLE,  SC  29601
Correspondent Contact PHIL CUSCUNA
Regulation Number892.1715
Classification Product Code
MUE  
Date Received05/11/2011
Decision Date 12/22/2011
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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