K-number	K062405
Device name	XPLORER 1590
Applicant	Imaging Dynamics Company , Ltd.
Product code	KPR
Device class	Class II
Decision date	Sep 13, 2006
Decision	Substantially Equivalent
Regulation	892.1680

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View the full FDA submission: accessdata.fda.gov

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XPLORER 1590

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