Name: Predicase
Price: 199 USD

K-number	K122454
Device name	FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
Applicant	Fujifilm Medical System U.S.A., Inc.
Product code	KPR
Device class	Class II
Decision date	Nov 20, 2012
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION

Everything you need for a 510(k) submission. Nothing you don't.