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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
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