K-number	K180019
Device name	CAAS Workstation
Applicant	Pie Medical Imaging BV
Product code	IZI
Device class	Class II
Decision date	May 3, 2018
Decision	Substantially Equivalent
Regulation	892.1600

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Source

View the full FDA submission: accessdata.fda.gov

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CAAS Workstation

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