Name: Predicase
Price: 199 USD

K-number	K111646
Device name	ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
Applicant	Fujifilm Medical System U.S.A., Inc.
Product code	MUE
Device class	Class II
Decision date	Dec 8, 2011
Decision	Substantially Equivalent
Regulation	892.1715

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Source

View the full FDA submission: accessdata.fda.gov

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ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

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