K-number	K191007
Device name	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
Applicant	Supersonic Imagine
Product code	IYN
Device class	Class II
Decision date	Oct 25, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

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