K-number	K111324
Device name	CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
Applicant	Agfa Healthcare N.V.
Product code	MUE
Device class	Class II
Decision date	Dec 22, 2011
Decision	Substantially Equivalent
Regulation	892.1715

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Source

View the full FDA submission: accessdata.fda.gov

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CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

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