Name: Predicase
Price: 199 USD

K-number	K091073
Device name	WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
Applicant	Ultraspect , Ltd.
Product code	KPS
Device class	Class II
Decision date	May 14, 2009
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS

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