K-number	K173597
Device name	Scenium VE20 Software
Applicant	Siemens Medical Solutions USA, Inc.
Product code	LLZ
Device class	Class II
Decision date	Apr 4, 2018
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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Scenium VE20 Software

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