K-number	K153736
Device name	3mensio Workstation
Applicant	Pie Medical Imaging BV
Product code	LLZ
Device class	Class II
Decision date	May 27, 2016
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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3mensio Workstation

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