K-number	K041380
Device name	IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
Applicant	R2 Technology, Inc.
Product code	OEB
Device class	Class II
Decision date	Jun 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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IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR

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