K-number	K193319
Device name	XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Applicant	Vasoptic Medical, Inc.
Product code	HKI
Device class	Class II
Decision date	Jun 1, 2020
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

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