Name: Predicase
Price: 199 USD

K-number	K131448
Device name	3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
Applicant	Koelis
Product code	LLZ
Device class	Class II
Decision date	Jul 26, 2013
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION

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