K-number	K042605
Device name	COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Applicant	Siemens AG Medical Solutions
Product code	NWE
Device class	Class II
Decision date	Oct 8, 2004
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

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