K-number	K190995
Device name	ExactVu High Resolution Micro-Ultrasound System
Applicant	Exact Imaging, Inc.
Product code	IYN
Device class	Class II
Decision date	May 10, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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ExactVu High Resolution Micro-Ultrasound System

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