K-number	K110729
Device name	ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	MUE
Device class	Class II
Decision date	Sep 1, 2011
Decision	Substantially Equivalent
Regulation	892.1715

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View the full FDA submission: accessdata.fda.gov

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ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM

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