K-number	K071513
Device name	INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Applicant	Siemens Medical Solutions
Product code	JAK
Device class	Class II
Decision date	Jun 26, 2007
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

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