K-number	K162055
Device name	Acclarix LX8 Diagnostic Ultrasound System
Applicant	Edan Instruments, Inc.
Product code	IYN
Device class	Class II
Decision date	Jan 31, 2017
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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Acclarix LX8 Diagnostic Ultrasound System

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