K-number	K192761
Device name	Asimov-MKS Imaging System
Applicant	Onlume, Inc.
Product code	IZI
Device class	Class II
Decision date	Jan 17, 2020
Decision	Substantially Equivalent
Regulation	892.1600

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Source

View the full FDA submission: accessdata.fda.gov

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Asimov-MKS Imaging System

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