Name: Predicase
Price: 199 USD

K-number	K042023
Device name	FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
Applicant	Fujifilm Medical System U.S.A., Inc.
Product code	MQB
Device class	Class II
Decision date	Aug 25, 2004
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER

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